Arthrex® AR-8935-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867050402), received between Dec 27, 2017 and Feb 18, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Positioning Failure

  ON 30-JAN-2026, AN ARTHREX EMPLOYEE REPORTED VIA PHONE THAT (2) AR-8935L-14 LOW PROFILE LOCKING SCREWS FAILED TO LOCK INTO THE PLATE. THIS OCCURRED DURING AN ANKLE FRACTURE CASE ON (B)(6) 2026. THE CASE WAS COMPLETED USING ADDITIONAL AR-8935L-14 LOW PROFILE LOCKING SCREWS. THERE WAS NO DELAY IN THE PROCEDURE, AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376723 ↗
• MalfunctionFeb 18, 2026Positioning Failure

  ON 30-JAN-2026, AN ARTHREX EMPLOYEE REPORTED VIA PHONE THAT (2) AR-8935L-14 LOW PROFILE LOCKING SCREWS FAILED TO LOCK INTO THE PLATE. THIS OCCURRED DURING AN ANKLE FRACTURE CASE ON (B)(6) 2026. THE CASE WAS COMPLETED USING ADDITIONAL AR-8935L-14 LOW PROFILE LOCKING SCREWS. THERE WAS NO DELAY IN THE PROCEDURE, AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376718 ↗
• MalfunctionAug 9, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT HEAD OF AN AR-8935-14 NON-LOCKING LOW PROFILE SCREW BROKE OFF. THE SCREW WAS INSERTED WITHOUT ISSUES, WHEN A SECOND AND LARGER SCREW WAS BEING INSERTED, THE HEAD OF AN AR-8935-14 NON-LOCKING LOW PROFILE SCREW BROKE OFF. THE HEAD WAS RETRIEVED FROM THE PATIENT, BUT THE BODY OF THE SCREW WAS LEFT IMPLANTED. THE CASE CONTINUED WITHOUT ISSUES, WITH THE SAME PLATE AND ADDITIONAL SCREW. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19949398 ↗
• MalfunctionMar 20, 2024Break; Break

  ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8935-14 LOW PROFILE SCREWS HEAD BROKE OFF. THIS OCCURRED DURING AN ANKLE FRACTURE ON 02/21/2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024, WHERE THE SALES REPRESENTATIVE REPORTED THAT THE SCREW HEAD BROKE OFF DURING INSERTION, AND THE SHAFT OF THE SCREW REMAINS IN THE PATIENT. AN AR-8943-30 WAS USED TO PREPARE THE BONE, AND THE PATIENT HAD A VERY HARD BONE. A LONGER TI 1/3 TUBULAR PLATE AND SCREWS WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18942596 ↗
• InjuryAug 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52PTS QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 52MM, LOT/SERIAL (B)(6). AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL (B)(6). AR-8933-20 LO-PRO SCRW,TI,3.0MMX 20MMCORT, LOT/SERIAL (B)(6). AR-8933V-12 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-14 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-16 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-18 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-20 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8935-12 LO-PRO SCRW,TI,3.5MMX 12MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-26 LO-PRO SCRW,TI,3.5MMX 26MM, LOT/SERIAL (B)(6). AR-8943-01 GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL (B)(6). AR-8943-02 DRILL BIT, CANNULATED, 2.6MM, LOT/SERIAL (B)(6). AR-8943-16 2.0MM DRILL BIT, CALIBR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563205 ↗
• InjuryAug 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52PTS QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 52MM, LOT/SERIAL (B)(6). AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL (B)(6). AR-8933-20 LO-PRO SCRW,TI,3.0MMX 20MMCORT, LOT/SERIAL (B)(6). AR-8933V-12 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-14 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-16 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-18 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-20 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8935-12 LO-PRO SCRW,TI,3.5MMX 12MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-26 LO-PRO SCRW,TI,3.5MMX 26MM, LOT/SERIAL (B)(6). AR-8943-01 GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL (B)(6). AR-8943-02 DRILL BIT, CANNULATED, 2.6MM, LOT/SERIAL (B)(6). AR-8943-16 2.0MM DRILL BIT, CALIBR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563185 ↗
• MalfunctionNov 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-14 LOW PROFILE SCREW HEAD BROKE OFF THE BODY OF THE SCREW WHILE INSERTING IT. THIS WAS DISCOVERED DURING AN ORIF LT ANKLE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 10/19/2022: THE BODY OF THE SCREW REMAINS IMPLANTED IN THE PATIENT AND CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15743573 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PRODUCT TEAM THAT A SALES REP HAS REPORTED A POSSIBLE PATIENT REACTION INCIDENT INVOLVING AN ARTHREX VOLAR PLATE. THE MATERIAL COMPOSITION INFORMATION WAS PROVIDED TO THE SALES REP, FOR THE SURGEON, BY THE PRODUCT TEAM. ADDITIONAL INFORMATION PROVIDED 6/1/20: THE PATIENT HAD UNDERGONE A DISTAL RADIUS FRACTURE ORIF PROCEDURE ON (B)(6) 2020. THE PATIENT HAD THE INITIAL POST OP VISIT ON (B)(6) 2020 AT WHICH TIME THE PATIENT WAS TAKEN TO THE OR FOR AND IRRIGATION AND DEBRIDEMENT FOR A PRESUMED INFECTION. CULTURES HAS ALL BEEN NEGATIVE: NEGATIVE AEROBIC, ANAEROBIC, FUNGAL AND AFB. SYMPTOMS OF DRAINAGE, BLISTERING, RASHES AND WOUND HEALING ISSUES HAVE ALL BEEN ASSESSED BY THE SURGEON, INFECTIOUS DISEASE AND DERMATOLOGY. PATIENT HAS BEEN TREATED TO DATE WITH STEROIDS AND ANTIBIOTICS (TOPICAL AND ORAL). IT IS UNKNOWN IF PATIENT HAS BEEN TESTED FOR SPECIFIC KNOWN ALLERGIES HOWEVER IT HAS BEEN REPORTED THAT PATIENT HAS DEVELOPED ALLERGIC REACTION TO ALMOST EVERYTHING (ADHESIVE, SUTURE, PREP, MULTIPLE ANTIBIOTICS). THE PATIENT HAS AN ALLERGIST VISIT SCHEDULED FOR (B)(6) 2020. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE IMPLANTED DURING THE 3/3/20 PROCEDURE: AR-

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184179 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PRODUCT TEAM THAT A SALES REP HAS REPORTED A POSSIBLE PATIENT REACTION INCIDENT INVOLVING AN ARTHREX VOLAR PLATE. THE MATERIAL COMPOSITION INFORMATION WAS PROVIDED TO THE SALES REP, FOR THE SURGEON, BY THE PRODUCT TEAM. ADDITIONAL INFORMATION PROVIDED 6/1/2020: THE PATIENT HAD UNDERGONE A DISTAL RADIUS FRACTURE ORIF PROCEDURE ON (B)(6) 2020. THE PATIENT HAD THE INITIAL POST OP VISIT ON (B)(6) 2020 AT WHICH TIME THE PATIENT WAS TAKEN TO THE OR FOR AND IRRIGATION AND DEBRIDEMENT FOR A PRESUMED INFECTION. CULTURES HAS ALL BEEN NEGATIVE: NEGATIVE AEROBIC, ANAEROBIC, FUNGAL AND AFB. SYMPTOMS OF DRAINAGE, BLISTERING, RASHES AND WOUND HEALING ISSUES HAVE ALL BEEN ASSESSED BY THE SURGEON, INFECTIOUS DISEASE AND DERMATOLOGY. PATIENT HAS BEEN TREATED TO DATE WITH STEROIDS AND ANTIBIOTICS (TOPICAL AND ORAL). IT IS UNKNOWN IF PATIENT HAS BEEN TESTED FOR SPECIFIC KNOWN ALLERGIES HOWEVER IT HAS BEEN REPORTED THAT PATIENT HAS DEVELOPED ALLERGIC REACTION TO ALMOST EVERYTHING (ADHESIVE, SUTURE, PREP, MULTIPLE ANTIBIOTICS). THE PATIENT HAS AN ALLERGIST VISIT SCHEDULED FOR (B)(6) 2020. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE IMPLANTED DURING THE (B)(6) 2020 PROCEDU

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184110 ↗
• InjuryJan 9, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: CASE DATE OF IMPLANTATION: (B)(6) 2019. CASE DATE OF EXPLANTATION: NOT YET DETERMINED. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-12 LOT: 2542021. AR-8724V-12 LOT: 2605841. AR-8724V-18 LOT: 2605831. AR-8935-14 LOT: 10176201. AR-8935-14 LOT:10249431. THE SPECIFIC DATE OF THE SECOND SURGERY (EXPLANT) IS UNKNOWN, HOWEVER IT IS KNOWN THAT THE DATE WAS PRIOR TO (B)(6) 2019. FOR REPORTING PURPOSES (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF EVENT.

  Patient problems: Failure of Implant

  MAUDE report 9569953 ↗
• InjuryJan 9, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/2019: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: NOT YET DETERMINED, THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-12 LOT: 2542021, AR-8724V-12 LOT: 2605841, AR-8724V-18 LOT: 2605831, AR-8935-14 LOT: 10176201, AR-8935-14 LOT:10249431. NOTE: THE SPECIFIC DATE OF THE SECOND SURGERY (EXPLANT) IS UNKNOWN, HOWEVER IT IS KNOWN THAT THE DATE WAS PRIOR TO (B)(6) 2019. FOR REPORTING PURPOSES (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF EVENT.

  Patient problems: No Information

  MAUDE report 9569945 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/19: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: (B)(6) 2019. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8916SPN LOT: 105641930, AR-8724-10 LOT: W646301, AR-8724V-10 LOT: 2610171, AR-8724V-12 LOT: W657601, AR-8935-14 LOT: 10279504, AR-8935L-12 LOT: 10257929, AR-8935L-14 LOT: 10277889.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9557221 ↗
• InjuryDec 27, 2017Bent; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2017 WHERE A VOLAR DISTAL RADIUS PLATE (AR-8916VSL-03) WAS IMPLANTED ALONG WITH 5 CORTEX SCREWS. THE PATIENT AFTER INITIAL IMPLANTATION RETURNED HOME AND REPORTS NO FURTHER ISSUES UNTIL FOLLOW UP WITH THE SURGEON. ON (B)(6) 2017, A REVISION WAS PERFORMED TO EXPLANT THE VOLAR DISTAL RADIUS PLATE AND ALL 5 CORTEX SCREWS AS DURING THE PATIENT'S POST-OP APPOINTMENT, THE SURGEON FOUND THAT ALL 5 SCREWS WERE BENT AND HAD BACKED OUT OF THEIR RESPECTIVE LOCKING HOLES IN THE DISTAL RADIUS PLATE. THE SURGEON REPORTS THAT PATIENT HAD NO FALLS, EARLY RANGE OF MOTION OR OTHER EVENT THAT COULD HAVE OCCURRED THAT WOULD'VE CAUSED THIS ISSUE, HOWEVER HE BELIEVES THAT THE PATIENT COULD HAVE EXPERIENCED A FALL OR SOME TYPE OF EVENT THAT CAUSED THIS FAILURE TO OCCUR BUT THE PATIENT DOES NOT RELIABLY GIVE A HISTORY OF SUCH. PATIENT IS A FEMALE, (B)(6). THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-8916VNC-14, LOT: 151596 / LINE 216861; AR-8916VNC-16, LOT: 95141729 / LINE 217127; AR-8916VNC-18, LOT: 95241731 / LINE 217128; AR-8935-12, LOT: 10150458 / LINE 217129; AR-8935-14, LOT: 10158950

  Patient problems: Failure of Implant

  MAUDE report 7147515 ↗