Arthrex® AR-8935-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867131934), received between Dec 27, 2017 and Sep 9, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT ENROLLED IN THE HAND AND WRIST REGISTRY HAD DEVELOPED CARPAL TUNNEL SYNDROME. THE PATIENT HAD PREVIOUSLY PRESENTED FOR FOLLOW-UP ON (B)(6) 2025, REPORTING PROGRESSIVE NUMBNESS IN THE THUMB, INDEX, AND LONG FINGERS FOLLOWING SURGERY. ULTRASOUND EVALUATION OF THE RIGHT CARPAL TUNNEL REVEALED FINDINGS CONSISTENT WITH CARPAL TUNNEL SYNDROME. TO ALLEVIATE SYMPTOMS, THE PATIENT UNDERWENT RIGHT CARPAL TUNNEL RELEASE SURGERY ON (B)(6) 2025. THIS EVENT WAS DETERMINED TO BE RELATED TO THE KREULOCK SCREW UTILIZED DURING THE DISTAL RADIUS FRACTURE FIXATION PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 8/20/2025: DURING THE PROCEDURE ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH AN AR-8724VCL-18 VAL KREULOCK SCREW, AN AR-8724VCL-16 VAL KREULOCK SCREW, AN AR-8724VCL-14 VAL KREULOCK SCREW, AN AR-8935-12 LOW PROFILE SCREW, AND AN AR-8916VNR-03 VOLAR DISTAL RADIUS PLATE. NO ARTHREX PRODUCTS WERE EXPLANTED OR IMPLANTED DURING THE RIGHT CARPAL TUNNEL RELEASE SURGERY ON (B)(6) 2025. THE SURGEON CONFIRMED THAT THE PATIENT'S CARPAL TUNNEL SYNDROME IS NOT RELATED TO THE ARTHREX PRODUCTS, AS MANY PA

  Patient problems: Numbness

  MAUDE report 23005506 ↗
• 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 ON (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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563091 ↗
• 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 NOT LOCKED INTO 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-8724-10 LOT: 1058931, AR-8724V-10 LOT: W654331, AR-8724V-16 LOT: W630941, AR-8935-12 LOT: 10220124, AR-8935L-12 LOT: 10248943, AR-8935L-12 LOT: 10257929. 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 9570060 ↗
• InjurySep 19, 2018Appropriate Device Problem Term/Code Not Available

  DURING SOCIAL SAFEGUARD CYBER REVIEW (ARTHREX CHATTER COMMUNITY) A POTENTIAL DEVICE ISSUE WAS DISCOVERED. UPON FURTHER INVESTIGATION IT WAS CONFIRMED ON (B)(6) 2018 THAT A REVISION PROCEDURE HAD TAKEN PLACE. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION OBTAINED 9/5/2018: A PATIENT HAD A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8916VNL-03 LOT 10183688 (QTY 1), AR-8724V-20 (QTY 4 LOT UNKNOWN), AR-8935L12 (QTY 1 LOT UNKNOWN), AR-8935L-14 (QTY 1 LOT UNKNOWN), AND AR-8935-12 (QTY1 LOT UNKNOWN). THE PATIENT SUFFERED A FALL AND HAD A REVISION PROCEDURE ON (B)(6) 2018. DURING THE REVISION PROCEDURE ALL OF THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED. THE FOLLOWING DEVICES WERE IMPLANTED TO COMPLETE THE PROCEDURE: AR-8916VNL-03 LOT 10189728 (QTY1), AR-8724V-18 (QTY1 LOT UNKNOWN), AR-8724V-22 (QTY 3 LOT UNKNOWN), AR-8935L-12 (QTY1 LOT UNKNOWN), AR-8935L-14 (QTY 1 LOT UNKNOWN), AND AR-8935-12 (QTY1 LOT UNKNOWN). PER REPORTER IT IS UNKNOWN WHEN THE PATIENTS PAIN BEGAN OR IF PATIENT HAD ANY OTHER SYMPTOMS PRIOR TO THE PATIENT'S FALL. NO CULTURES WERE TAKEN OR ANY OTHER PROBLEMS FOUND DURING REVISION SURGERY

  Patient problems: Fall; Pain

  MAUDE report 7890144 ↗
• InjuryDec 27, 2017Bent; Device Dislodged or Dislocated

  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: No Code Available

  MAUDE report 7147522 ↗