Arthrex® AR-8916VSR-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867131156), received between Jun 9, 2020 and Sep 28, 2026 — classified as 4 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914725 ↗
• MalfunctionApr 21, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 3/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A VAL SCREW ADVANCE STRAIGHT THROUGH AN AR-8916VSR-05 VOLAR DISTAL RADIUS PLATE. THE SCREW WAS REMOVED, AND ANOTHER 2.4 VAL SCREW WAS INSERTED, BUT THE SAME THING HAPPENED. THIS WAS DISCOVERED DURING A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21875101 ↗
• MalfunctionApr 17, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 4/15/2025: NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED WITH A NEW PLATE AND SCREWS. HOWEVER, THE PROCEDURE WAS DELAYED BY APPROXIMATELY FORTY-FIVE MINUTES, REQUIRING THE ADMINISTRATION OF ADDITIONAL ANESTHESIA. ADDITIONAL INFORMATION WAS REQUESTED ON 5/6/2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855556 ↗
• InjuryOct 6, 2023Break; Break

  IT WAS REPORTED THAT A DISTAL RADIUS OSTEOTOMY REVISION SURGERY WAS PERFORMED ON (B)(6)2023, TO REPLACE A BROKEN-OFF VOLAR DISTAL RADIUS PLATE. A FEW WEEKS AFTER THE REVISION SURGERY THE PLATE BROKE AGAIN AND HAD TO BE REPLACED WITH THE SAME TYPE OF IMPLANT IN AN ADDITIONAL SURGERY ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17884648 ↗
• InjuryOct 3, 2023Break; Break

  IT WAS REPORTED THAT A DISTAL RADIUS OSTEOTOMY REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REPLACE A BROKEN-OFF VOLAR DISTAL RADIUS PLATE. A FEW WEEKS AFTER THE REVISION SURGERY THE PLATE BROKE AGAIN A SECOND TIME AND HAD TO BE REPLACED AGAIN. A PLATE FROM A COMPETITOR WAS USED TO FINISH THE SURGERY SUCCESSFULLY AND THIS SURGERY WAS PERFORMED ON (B)(6) 2023. THE BROKEN IMPLANT WAS COMPLETELY RETRIEVED FROM PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 17862862 ↗
• InjuryOct 3, 2023Break; Break

  IT WAS REPORTED THAT THE VOLAR DISTAL RADIUS PLATE BROKE A FEW WEEKS POST-OP. NO FURTHER INFORMATION RECEIVED. UPDATE 07-SEP-2023 NROE: FURTHER INFORMATION REVEALED THAT DURING A DISTAL RADIUS OSTEOTOMY A VOLAR DISTAL RADIUS PLATE WAS IMPLANTED INTO THE PATIENT. A FEW WEEKS AFTER THE INITIAL SURGERY THE PLATE BROKE AND HAD TO BE REPLACED WITH THE SAME TYPE OF IMPLANT IN AN ADDITIONAL SURGERY ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17862702 ↗
• InjuryJun 9, 2020Inadequacy of Device Shape and/or Size; Use of Device Problem

  AN ARTHREX SALES REP WAS NOT PRESENT DURING THE PROCEDURE. IT WAS REPORTED TO THE SALES REP THAT THE SURGEON WAS USING AN ARTHREX 5 HOLE STANDARD VOLAR PLATE (REP STATES THE PLATE WAS BELIEVED TO BE A RIGHT PLATE BASED ON THE X-RAY), AR-8916VSR-05, FROM A DRP SET. THE SET WAS A LOANER SET THAT HAD BEEN BROUGHT IN FOR A PREVIOUS CASE AND DUE TO COVID-19 IT WAS UNABLE TO BE RETRIEVED. THE SET WAS CALLED FOR AGAIN FOR THIS CASE. HE USED THE 1.7MM DRILL, AR-8916-14, THE DROP IN VAL GUIDE, AR-8916-21 (NOT AN EXTREME ANGLE), AND THEN PUT IN AN ARTRHERX 2.4MM GOLD VAL LOCKING SCREW, AR-8724V-XX (LENGTH UNKNOWN), INTO ONE OF THE DISTAL HOLES OF THE PLATE. SURGEON REPORTED TO THE SALES REP THAT THE PROCEDURE WAS ALL BY THE BOOK. THE LOCKING SCREW WENT INTO THE HOLE AND HAD JUST A TINY BIT OF BITE AND THEN IT JUST SPUN IN THE PLATE HOLE. IT IS REPORTED TO THE SALES REP THAT OVER TENSIONING DID NOT OCCUR. SURGEON TRIED A LOCKING SCREW, 2.4MM VAL LOCKING SCREW, AR-8724V-XX (SIZE UNKNOWN), IN ANOTHER PLATE TO TEST FEEL WHAT IT SHOULD BE LIKE INTRA OP AND IT HAD GOOD BITE. AFTER THE FIRST LOCKING SCREW SPUN IN THE HOLE, THE SURGEON TRIED ANOTHER SCREW IN THE SAME HOLE WITH THE SAME RESULT. SURGE

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 10133205 ↗