Arthrex® AR-8835-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867047297), received between Jul 25, 2018 and Mar 4, 2026 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 21-OCT-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 24506277 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE SURGERY THE PLATE BROKE IN THE MIDDLE DURING FASTENING. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750451 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE SURGERY THE PLATE BROKE IN THE MIDDLE DURING FASTENING. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750449 ↗
• InjuryMay 12, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT'S CLAVICLE FRACTURE PLATE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2025, A PATIENT¿S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A CLAVICLE PLATE FRACTURED. THE PLATE WAS IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT CLAVICLE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, IMAGING SHOWED A BENT CLAVICLE PLATE. ON (B)(6) 2024, IMAGING SHOWED A FRACTURED CLAVICLE PLATE. ON (B)96) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. THE RECORDS INDICATED PATIENT NONCOMPLIANCE WITH POSTOPERATIVE PROTOCOL CONTRARY TO THE CLAVICLE PLATE'S DIRECTIONS FOR USE.

  Patient problems: Failure of Implant

  MAUDE report 22001338 ↗
• 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 21865615 ↗
• 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 21322655 ↗
• InjuryFeb 16, 2024Break; Break

  ON 1/18/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2685DR-10 DISTAL CLAVICLE PLATE BROKE EIGHT WEEKS POST-OPERATIVE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT COMMINUTED MID-SHIFT CLAVICLE FRACTURE. EIGHT WEEKS LATER, THE PATIENT RETURNED TO THE CLINIC, EXPERIENCING PAINFUL POPS IN THE SHOULDER. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE AR-2685DR-10 DISTAL CLAVICLE PLATE. THE REVISION SURGERY WAS A REVISION OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT CLAVICLE FRACTURE WITH ILIAC BONE GRAFT AND RIGHT CLAVICLE HARDWARE REMOVAL. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/23/2024: DURING THE ORIGINAL PROCEDURE ON (B)(6) 2023, AN AR-2685DR-10 DISTAL CLAVICLE PLATE, AN AR-8827L-20 LOW PROFILE LOCKING SCREW, (4) AR-8827L-18 LOW PROFILE LOCKING SCREW, (2) AR-8835-16 LOW PROFILE SCREW, AN AR-8835-18 LOW PROFILE SCREW, (2) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW WERE IMPLANTED. DURING THE REVISION SURGERY ON (B)(6) 2023, ALL THE IMPLANTS WERE SUCCESSFULLY REMOVED.

  Patient problems: Implant Pain

  MAUDE report 18725299 ↗
• InjuryFeb 16, 2024Break; Break

  ON 1/18/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2685DR-10 DISTAL CLAVICLE PLATE BROKE EIGHT WEEKS POST-OPERATIVE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT COMMINUTED MID-SHIFT CLAVICLE FRACTURE. EIGHT WEEKS LATER, THE PATIENT RETURNED TO THE CLINIC, EXPERIENCING PAINFUL POPS IN THE SHOULDER. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE AR-2685DR-10 DISTAL CLAVICLE PLATE. THE REVISION SURGERY WAS A REVISION OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT CLAVICLE FRACTURE WITH ILIAC BONE GRAFT AND RIGHT CLAVICLE HARDWARE REMOVAL. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/23/2024: DURING THE ORIGINAL PROCEDURE ON (B)(6) 2023, AN AR-2685DR-10 DISTAL CLAVICLE PLATE, AN AR-8827L-20 LOW PROFILE LOCKING SCREW, (4) AR-8827L-18 LOW PROFILE LOCKING SCREW, (2) AR-8835-16 LOW PROFILE SCREW, AN AR-8835-18 LOW PROFILE SCREW, (2) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW WERE IMPLANTED. DURING THE REVISION SURGERY ON (B)(6) 2023, ALL THE IMPLANTS WERE SUCCESSFULLY REMOVED.

  Patient problems: Implant Pain

  MAUDE report 18723015 ↗
• 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 18637526 ↗
• 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 18637523 ↗
• 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 17326428 ↗
• InjuryMay 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON THE (B)(6) 2023: AR-2652CL (LOT: 5262102); AR-8835L-16 (LOT: 14975878); AR-8835L-18 (LOT: 14975879), AR-8835-16 (LOT: 14999011) AND AR-8835-18 (LOT: 14983034). THE PLATE BENT POST-OP WITHOUT EXTERNAL INFLUENCE. ON THE (B)(6) 2023, IT WAS REMOVED AND REPLACED WITH A NEW CLAVICLE FRACTURE PLATE (AR-2652CL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16904837 ↗
• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON (B)(6) 2022: AR-2651CL (LOT: 5262203); AR-8835-16 (ILOT: 14999011); AR-8835L-16 (LOT: 14975878) AND AR-8835L-18 (LOT: 14946776). THE PLATE BROKE POST-OP WITHOUT EXTERNAL INFLUENCE. ON (B)(6) 2023 IT WAS REMOVED AND REPLACED WITH A NEW CLAVICLE FRACTURE PLATE (AR-2652CL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16904808 ↗
• MalfunctionJun 13, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2652CR CLAVICLE FRACTURE PLATE WAS IMPLANTED IN PATIENT ON (B)(6) 2022 DURING A CLAVICLE FRACTURE. PATIENT FELT THE PLATE BREAK AND ON (B)(6) 2022, IT WAS CONFIRM VIA X-RAYS THAT THE PLATE HAD BROKEN. A REVISION SURGERY HAS BEEN SCHEDULE BY THE SAME SURGEON THAT PERFORMED THE ORIGINAL PROCEDURE AND IT WILL TAKE PLACE AT THE SAME FACILITY. THIS REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2022 TO REMOVE ALL THE IMPLANTED SCREWS ALONG WITH THE BROKEN PLATE. ADDITIONAL INFORMATION RECEIVED ON 5/26/2022: DURING ORIGINAL PROCEDURE, SURGEON IMPLANTED THE FOLLOWING: ONE AR-2652CR CLAVICLE FRACTURE PLATE, ONE AR-2665-16H FRAGMENT SCREW, ONE AR-2665-18H FRAGMENT SCREW, ONE AR-2665-20H FRAGMENT SCREW, ONE AR-2665-22H FRAGMENT SCREW, ONE AR-8835-16 LOW PROFILE SCREW, ONE AR-8835-18 LOW PROFILE SCREW, TWO AR-8835-20 LOW PROFILE SCREWS, ONE AR-8835L-16 LOW PROFILE LOCKING SCREW, AND THREE AR-8835L-18 LOW PROFILE LOCKING SCREW. ALL THESE IMPLANTS WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY USING SYNTHES WITHOUT FURTHER ISSUES.

  Patient problems: Failure of Implant

  MAUDE report 14675312 ↗
• 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 (B)(6) 2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON (B)(6) 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 PANDE

  Patient problems: No Code Available

  MAUDE report 10108661 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A LEFT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019. DUE TO PATIENT ISSUES WITH PAINFUL HARDWARE. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY CENTER. ALL ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED DURING THE REVISION. NO PRODUCTS WERE IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION. THE PRODUCTS WERE KEPT BY THE PATIENT. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE EXPLANTED: AR-2655CL, CLAVICLE FRACTURE PLATE, CENTRAL THIRD -LEFT, (LOT 5261832), AR-2665-14H, FRAGMENT SCREW, (LOT 135138), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10240456), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10248912).

  Patient problems: Pain

  MAUDE report 9473156 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A LEFT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019. DUE TO PATIENT ISSUES WITH PAINFUL HARDWARE. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY CENTER. ALL ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED DURING THE REVISION. NO PRODUCTS WERE IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION. THE PRODUCTS WERE KEPT BY THE PATIENT. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE EXPLANTED: AR-2655CL, CLAVICLE FRACTURE PLATE, CENTRAL THIRD -LEFT, (LOT 5261832), AR-2665-14H, FRAGMENT SCREW, (LOT 135138), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10240456), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10248912).

  Patient problems: Pain

  MAUDE report 9473154 ↗
• 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: Bacterial Infection

  MAUDE report 7718948 ↗