Arthrex® AR-8916VSL-03SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867211735), received between Mar 24, 2025 and May 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT WHEN INSERTING AN AR-8724V-20S (LOW PROFILE VA LOCKING SCREW, 2.4 X 20 MM, STERILE), IT PASSED THROUGH THE PLATE (AR-8916VSL-03S VOLAR DISTAL RADIUS PLATE, TI, STANDARD, LEFT, 3 HOLE) WITHOUT BEING LOCKED AND WAS LEFT INSIDE THE PATIENT'S BONE. THIS OCCURRED DURING A DISTAL RADIUS FRACTURE CASE ON (B)(6) 2025. THE METHOD OF INSERTING THE SCREW WAS FIRSTLY TO AFFIX THE AR-8916-02 (AIMING GUIDE VDR PLATE STANDARD L) TO THE PLATE BEFORE INSERTING THE SCREW. THE SCREW IS NOT SWUNG WITH THE VARIABLE SCREW, AND THE ANGLE IS FIXED. THE DRIVER USED WAS AR-8916TL-011, AND THE SCREW WAS NOT INSERTED WITH EXCESSIVE FORCE. THE OTHER SCREWS WERE LOCKED WITHOUT ANY PROBLEMS. AT THE DOCTOR'S DISCRETION, THE PLATE AND BURIED AR-8724V-20S SCREW WERE LEFT IN THE PATIENT'S BODY AND THE SURGERY WAS COMPLETED. ONLY THE DRIVER AND AIMING GUIDE WILL BE RETURNED TO ARTHREX. THE PROCEDURE WAS NOT CONSIDERED TO BE COMPLETED SUCCESSFULLY AS THE AR-8724V-20S SCREW IN QUESTION WAS IN AN INCOMPLETE FIXED STATE WHILE THERE WERE NO PROBLEMS WITH THE SCREW FIXATION IN OTHER AREAS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22026339 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A DISTAL RADIUS FRACTURE SURGERY THE DRP PLATE AR-8916VSL-03S (LOT: 15167246) FAILED IN THE TOP-LEFT LOCKING HOLE. IT WAS NOT POSSIBLE TO INSERT THE LOCKING SCREW, AS IT JUST DIDN¿T HOLD THE SCREW. THE SURGEON SWITCHED TO ANOTHER PLATE AR-8916VSL-03S (LOT: 15167246) AND THE SCREW GOT STUCK IN THE LOCKING HOLE ON THE SECOND PLATE. THE SCREW GOT ALMOST WELDED INTO THE PLATE, AND THE SURGEON COULDN`T REMOVE IT, AND ACCEPTED THE POSITION EVEN THOUGH NOT IDEAL. THE SECOND PLATE REMAINED IN THE PATIENT, IN AN ACCEPTABLE WAY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SECOND PLATE WITH THE SAME PART- AND LOT NO. AS THE FIRST ONE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678766 ↗