Arthrex® AR-8835-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867047280), received between Feb 13, 2018 and Apr 22, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CALLED IN REPORTING THAT AFTER UNDERGOING AN ANKLE PROCEDURE IN (B)(6) OF 2025, SHE HAD EXPERIENCED A REACTION, ALONG WITH EXPERIENCING HER SKIN CHANGING, AND PAIN NEAR HER ANKLE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2026 WHERE THE PATIENT REPORTED THAT SHE UNDERWENT A LEFT ANKLE PROCEDURE FOR A DISPLACED BIMALLEOLAR FRACTURE OF THE LOWER LEG ON (B)(6) 2025 WHERE AN AR-8943DL-04 LOCKING DISTAL FIBULA PLATE, AR-8827-18 LOW PROFILE SCREW¿, 2.7 X 18 MM, (3) AR-8827CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 12 MM, AR-8827CL-14 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 14 MM, (2) AR-8827CL-16 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 16 MM, (3) AR-8835CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 3.5 MM X 12 MM, AR-8835-14 LOW PROFILE SCREW¿, SS, 3.5 X 14 MM, CORTICAL, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE® XP, STAINLESS STEEL WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE THE FOLLOWING SYMPTOMS IN (B)(6) OF 2025; RUNNY NOSE, DIARRHEA, BLURRED VISION, SENSITIVITY TO THE ANKLE, BOTTOM OF THE TOES ACHE, CHANGES IN SKIN, BLOOD PRESSURE GOING UP AND DOWN, BACK OF HEELS ACHE, ITCHY ANKLE; THAT IS BEING TREATED WITH A CREAM, SHARP PAIN IN THE ANKLE, RIGHT EA

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 24957159 ↗
• InjuryMar 4, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, A HEALTH CARE PROFESSIONAL REPORTED VIA EMAIL THAT A CLAVICLE PLATE IMPLANTED IN A PATIENT EXPERIENCED A FAILURE. ACCORDING TO THE REPORT, THE FAILURE OCCURRED APPROXIMATELY SIX MONTHS POST IMPLANTATION, AND NO TRAUMA WAS NOTED DURING THAT PERIOD. RADIOGRAPHIC IMAGES OF THE PLATE FAILURE WERE PROVIDED FOR REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2025: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2025, INVOLVING AN ORIF OF THE RIGHT CLAVICLE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, INCLUDING NO CASE DELAYS, ADDED ANESTHESIA TIME, OR ADVERSE EVENTS. THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE PROCEDURE WERE NOT PROVIDED. THE IMPLANT FAILURE WAS IDENTIFIED SIX MONTHS POSTOPERATIVELY, OCCURRING AT THE JUNCTION BETWEEN THE SCREW HOLES. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2025: THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE INITIAL PROCEDURE HAVE NOT BEEN PROVIDED AT THIS TIME. A REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN TWO WEEKS. THE PATIENT DID NOT REPORT ANY PRIOR SYMPTOMS OR EXPERIENCE A POPPING SENSATION AT THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 24512123 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 04/03/2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPORT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22056390 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 04/03/2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPORT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22056366 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPOR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22056320 ↗
• MalfunctionApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPOR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21865617 ↗
• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction

  MAUDE report 21764307 ↗
• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21764241 ↗
• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21764228 ↗
• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6) 2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBIL

  Patient problems: Foreign Body Reaction

  MAUDE report 21322658 ↗
• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6) 2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBIL

  Patient problems: Foreign Body Reaction

  MAUDE report 21322643 ↗
• InjuryFeb 4, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023 WHERE AN AR-2652CL CLAVICLE FRACTURE PLATE, AN AR-8835-14 LOW PROFILE SCREW, (2) AR-8835-16 LOW PROFILE SCREWS, AN AR-8835CL-12 KREULOCK COMPRESSION SCREW, (2) AR-8835CL-14 KREULOCK COMPRESSION SCREWS, AN AR-8835-10 LOW PROFILE SCREW, AN AR-7268 FIBERTAPE® CERCLAGE WITH TIGERLINK, AND AN AR-7268T TIGERTAPE® CERCLAGE WITH FIBERLINK WERE IMPLANTED. FIVE WEEKS POST-OP, THE PATIENT REPORTED HEARING OR FEELING A POP. AN X-RAY WAS TAKEN THAT CONFIRMED THAT THE AR-2652CL PLATE HAD BROKEN. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTED DEVICES WERE REMOVED. THE REVISION WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 18637534 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE SCREW HAS LOOSENED IN THE CLAVICLE PLATE. NO FURTHER INFORMATION RECEIVED. 27-JUN-2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES BECAME LOOSE POST OP. AR-2652CL BATCH: 5262102; AR-8835L-14 BATCH: 15040867; AR-8835-14 BATCH: 10694746; 2X AR-8835-16 BATCH: 1072011; 3X AR-8835-18 BATCH: 10591283 ; AR-8827-14 BATCH: 1074240. AS THE REPORTED DEVICES ARE AVAILABLE FOR RETURN A REVISION SURGERY HAD TO BE PERFORMED BUT NO FURTHER INFORMATION WERE PROVIDED WHEN THE REVISION SURGERY WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 17326413 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE (SEE ATTACHED). THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1. AR-8835-14 // LOT: 10266334 X 1. AR-8835-14 // LOT: 10268858 X 1. AR-8835-14 // LOT: 10273289 X 1. AR-8835-14 // LOT: 10291574 X 1. AR-8835-16 // LOT: 10221152 X 1. AR-8835-18 // LOT: 10211116 X 1. AR-8835-18 // LOT: 10223067 X 1. AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/20: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO

  Patient problems: No Code Available

  MAUDE report 10108655 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 10266334 X 1, AR-8835-14 // LOT: 10268858 X 1, AR-8835-14 // LOT: 10273289 X 1, AR-8835-14 // LOT: 10291574 X 1, AR-8835-16 // LOT: 10221152 X 1, AR-8835-18 // LOT: 10211116 X 1, AR-8835-18 // LOT: 10223067 X 1, AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/20: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19 P

  Patient problems: No Code Available

  MAUDE report 10108635 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 10266334 X 1, AR-8835-14 // LOT: 10268858 X 1, AR-8835-14 // LOT: 10273289 X 1, AR-8835-14 // LOT: 10291574 X 1, AR-8835-16 // LOT: 10221152 X 1, AR-8835-18 // LOT: 10211116 X 1, AR-8835-18 // LOT: 10223067 X 1, AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/2020: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19

  Patient problems: No Code Available

  MAUDE report 10108556 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON 12/18/2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 102663341 X 1, AR-8835-14 // LOT: 102688581 X 1, AR-8835-14 // LOT: 102732891 X 1, AR-8835-14 // LOT: 102915741 X 1, AR-8835-16 // LOT: 102211521 X 1, AR-8835-18 // LOT: 102111161 X 1, AR-8835-18 // LOT: 102230671 X 1, AR-8840-14 // LOT: 100357221 X 1. AT TIME OF INITIAL REPORT ON MARCH 9, 2020 OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED ON MARCH 20, 2020 THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/2020: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19 PA

  Patient problems: No Code Available

  MAUDE report 10108468 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ORIGINAL ANKLE PROCEDURE (B)(6) 2017. DURING THE SURGERY SIX ARTHREX PRODUCTS WERE IMPLANTED. THE PATIENT DEVELOPED ALLERGIC LIKE REACTION SYMPTOMS AND RECENTLY HAD TO UNDERGO A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE ARTHREX DEVICES. PATIENT DID NOT HAVE AN FURTHER DETAILS AT THE TIME OF REPORT BUT WILL PROVIDE SOON. ADDITIONAL INFORMATION 01/08/2020: ORIGINAL PROCEDURE WAS ON (B)(6) 2017 AND WAS A LEFT ANKLE ORIF. FOLLOWING SURGERY THE PATIENT WAS IN THE HOSPITAL FOR THREE NIGHTS. SHE STARTED HAVING RINGING IN HER EARS AND DIZZINESS 3 MONTHS AFTER SURGERY. THIS WAS FOLLOWED BY TIREDNESS, MIGRAINES, AND TMJ ON HER RIGHT SIDE. SHE ALSO DEVELOPED NOTICEABLY DRIER, FLAKY SKIN AND MORE ANXIETY AFTER ABOUT 6 MONTHS. SHE DEVELOPED FOOD INTOLERANCE TO DAIRY AND DEVELOPED A THYROID NODULE AS WELL. PATIENT HAD A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT ALL OF THE ORIGINAL IMPLANT DEVICES. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE FOLLOWING DEVICES WERE REPORTED TO HAVE BEEN IMPLANTED (B)(6) 2017 AND EXPLANTED (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): AR-8926SS, KNOTLESS TIGHT

  Patient problems: Anxiety; Dizziness; Fatigue; Headache; No Code Available; Reaction; Thyroid Problems; Tinnitus

  MAUDE report 9631389 ↗
• InjuryAug 21, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT'S RELATIVE HAS REPORTED THAT THE PATIENT HAD AN ANKLE ALLOGRAFT PROCEDURE IN (B)(6) 2018. DURING THE SURGERY AN ARTHREX PLATE AND SCREWS WERE IMPLANTED. SINCE THAT SURGERY THE PATIENT DEVELOPED MULTIPLE SYMPTOMS WHICH ARE BELIEVED TO BE AUTO-IMMUNE RELATED. THE PATIENT HAS TESTED POSITIVE FOR HAVING A NICKEL ALLERGY. PATIENT'S RELATIVE REPORTS THAT IT HAS BEEN SUGGESTED THAT IF PATIENT'S IMPLANTS CONTAIN NICKEL THIS COULD POSSIBLY BE THE CAUSE OF HER SYMPTOMS. SURGEON HAS TOLD THEM THE IMPLANTS RECEIVED DURING THE 2018 SURGERY WERE TITANIUM. REPORTER WAS REQUESTING THE MATERIAL COMPOSITION OF THE IMPLANT DEVICES TO DETERMINE IF THERE MAY POSSIBLY BE SOME NICKEL WITHIN THE COMPOSITION THAT COULD BE CAUSING THE PATIENT'S ISSUES. IN ADDITION TO THE AUTO-IMMUNE LIKE SYMPTOMS THE PATIENT'S RELATIVE STATES THAT THE PATIENT'S ANKLE REPAIR SURGERY WILL NEED TO BE REVISED BECAUSE THE REPAIR DID NOT WORK AND SHE IS UNABLE TO WALK OR PUT PRESSURE ON THAT ANKLE. SPECIFIC ARTHREX PART NUMBERS INVOLVED WERE UNKNOWN AT TIME OF INITIAL REPORT. REPORTER WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 7/31/2019: SALES REP HAS OBTAINED AND PROVIDED THE PATIENT IMPLANT PART NUMBERS.

  Patient problems: Autoimmune Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 8916278 ↗
• InjuryAug 21, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT'S RELATIVE HAS REPORTED THAT THE PATIENT HAD AN ANKLE ALLOGRAFT PROCEDURE IN (B)(6) 2018. DURING THE SURGERY AN ARTHREX PLATE AND SCREWS WERE IMPLANTED. SINCE THAT SURGERY THE PATIENT DEVELOPED MULTIPLE SYMPTOMS WHICH ARE BELIEVED TO BE AUTO-IMMUNE RELATED. THE PATIENT HAS TESTED POSITIVE FOR HAVING A NICKEL ALLERGY. PATIENT'S RELATIVE REPORTS THAT IT HAS BEEN SUGGESTED THAT IF PATIENT'S IMPLANTS CONTAIN NICKEL THIS COULD POSSIBLY BE THE CAUSE OF HER SYMPTOMS. SURGEON HAS TOLD THEM THE IMPLANTS RECEIVED DURING THE 2018 SURGERY WERE TITANIUM. REPORTER WAS REQUESTING THE MATERIAL COMPOSITION OF THE IMPLANT DEVICES TO DETERMINE IF THERE MAY POSSIBLY BE SOME NICKEL WITHIN THE COMPOSITION THAT COULD BE CAUSING THE PATIENT'S ISSUES. IN ADDITION TO THE AUTO-IMMUNE LIKE SYMPTOMS THE PATIENT'S RELATIVE STATES THAT THE PATIENT'S ANKLE REPAIR SURGERY WILL NEED TO BE REVISED BECAUSE THE REPAIR DID NOT WORK AND SHE IS UNABLE TO WALK OR PUT PRESSURE ON THAT ANKLE. SPECIFIC ARTHREX PART NUMBERS INVOLVED WERE UNKNOWN AT TIME OF INITIAL REPORT. REPORTER WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 7/31/2019: SALES REP HAS OBTAINED AND PROVIDED THE PATIENT IMPLANT PART NUMBERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8916255 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORIF OF LEFT CLAVICLE PROCEDURE ON (B)(6) 2018 WHERE AN AR-2652CL, LOT: UNK WAS IMPLANTED. ON (B)(6) 2018, AN INFECTION WAS NOTED ON HIS SKIN DURING HIS POST-OP VISIT. THE SURGEON ORDERED ANTIBIOTICS AND HAD CULTURES DONE. THE FACILITY IS CURRENTLY AWAITING THE RESULTS, HOWEVER, ACCORDING TO THE SURGEON, IT HAS COME BACK AS (B)(6). A REVISION SURGERY HAS NOT BEEN SCHEDULED AND IT IS UNKNOWN IF ONE WILL BE. THE FOLLOWING DEVICES WERE ALSO IMPLANTED DURING THE ORIF OF LEFT CLAVICLE PROCEDURE: AR-8835-14 3.5 CORTICAL SCREW 14MM X1; AR-8835-16 3.5 CORTICAL SCREW 16MM X2; AR-8835L-16 3.5 LOCKING SCREW 16MMX 3.

  Patient problems: Unspecified Infection

  MAUDE report 7718917 ↗
• InjuryJun 21, 2018Migration or Expulsion of Device; Mechanics Altered

  IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0MM DRILL. *ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) REGIONAL HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. DAVID ROWLEY. THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05, AR-8835-12 (QTY. 2), AR-8830-14 (QTY. 1), AR-8835-14 (QTY. 1), AR-8827L-14 (QTY. 3), AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2 MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731 // LOT: 10158067 // LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLA

  Patient problems: No Code Available

  MAUDE report 7625208 ↗
• InjuryFeb 21, 2018Break

  IT WAS REPORTED BY A DERMATOLOGIST'S OFFICE THAT A PATIENT IS CONCERNED HE IS ALLERGIC TO A COMPONENT OF THE PLATE AND SCREWS USED TO FIX HIS ANKLE IN 2015 AFTER HE SUFFERED A BREAK. REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE DEVICES. THE FOLLOWING ARE THE IMPLANTED DEVICES: AR-8943TH-05, LOCKING LATERAL HOOK PLATE, STAINLESS STEEL ((B)(4)). AR-8835-30, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-18, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-14, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8840-14, LOW PROFILE CANCELLOUS SCREW, STAINLESS STEEL ((B)(4)). AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. FOLLOW-UP INVESTIGATION: PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2014 (NOT 2015 AS ORIGINALLY REPORTED). SPECIFIC DATE IS UNKNOWN. SURGERY WAS AN ORIF OF THE LEFT ANKLE. PATIENT IS A MALE WITH KNOWN ALLERGY TO AMOXICILLIN. PATIENT HAS BEEN EXPERIENCING CHRONIC FATIGUE AND SLEEPINESS, ANXIETY AND PALPITATIONS AND BRADYCARDIA. TREATMENTS TO DATE ARE UNKNOWN. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES HAS BEEN PROVIDED THE REPORTER. DEVICES ARE STAINLESS STEEL. SINCE A SPECIFIC DAY FOR THE ORIGINAL (B)(6) 2014 SURGERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285137 ↗
• InjuryFeb 13, 2018Device Dislodged or Dislocated

  IT WAS REPORTED BY A FACILITY, WHO SENT A COPY OF A MEDWATCH (B)(4) WHICH THEY HAD FILED, THAT A PATIENT HAD ORIGINAL PLACEMENT OF HARDWARE THAT INCLUDED A PLATE AND SCREWS ON (B)(6) 2017 FOR A RIGHT DISPLACED LATERAL MALLEOLAR FRACTURE BY A HOSPITAL ORTHOPEDIC SURGEON. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2017 THE PATIENT WAS SEEN IN THE SURGEON'S OFFICE AND HAD COMPLAINTS OF INCREASING PAIN FOR THE PAST TWO MONTHS. THE PATIENT REPORTED TENDERNESS OVER PROMINENCE OF ONE OF THE SCREWS AS WELL AS THE ADDITIONAL AREA OF THE PLATE. THE SURGEON REVIEWED THE X-RAYS AND INDICATED NO CHANGE IN THE HARDWARE POSITION WITH NONE OF THE SCREWS BACKING OUT. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL WHERE THE ORTHOPEDIC SURGEON REPORTED THE FRACTURE AS HEALED BUT THE PATIENT REPORTED PAIN AND DYSFUNCTION WITH THE HARDWARE AND HAD WISHES FOR IT TO BE REMOVED. THE PATIENT HAD PLATE (AR-8943BR-04 LOCKING DISTAL FIBULA PLATE - (B)(4)) AND SCREW REMOVAL FROM HER RIGHT ANKLE UNDER GENERAL PLUS LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED. FOLLOW-UP INVESTIGATION: PER FACILITY MEDWATCH REPORTER, THE SURGEON'S OFFICE NOTES INDICATED THAT THERE WAS PAIN AND "PROMINENCE AT LOCKING SCRE

  Patient problems: Pain

  MAUDE report 7266953 ↗