Arthrex® AR-8935L-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867050846), received between Sep 19, 2018 and Jan 9, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2020Device Slipped

  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 Code Available

  MAUDE report 9570096 ↗
• InjuryJan 9, 2020Device Slipped

  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 Code Available

  MAUDE report 9570081 ↗
• 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 12/18/2019: 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 9557229 ↗
• InjurySep 19, 2018Positioning Problem

  DURING (B)(6) 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: Foreign Body In Patient

  MAUDE report 7890108 ↗