Arthrex® AR-8916VSR-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867131132), received between Sep 26, 2023 and Aug 31, 2026 — classified as 4 malfunctions.

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

• MalfunctionAug 31, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518471 ↗
• MalfunctionFeb 12, 2025Positioning Failure; Positioning Failure

  ON 01/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8916VSR-03 VOLAR DISTAL RADIUS PLATE EXPERIENCED AN ISSUE WITH A SCREW NOT LOCKING. THIS OCCURRED DURING A DISTAL RADIUS FRACTURE ON (B)(6) 2025 WHEN THE DISTAL SCREW WENT STRAIGHT THROUGH THE HOLE IN THE PLATE. THE PLATE WAS REMOVED. THE CASE CONTINUED USING THE OTHER PLATE IN THE TRAY WHICH WORKED ACCORDINGLY. THERE WAS A SLIGHT DELAY, WHERE THE REPRESENTATIVE DID NOT BELIEVE ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 21364218 ↗
• MalfunctionMay 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT WHEN SURGEON WENT TO INSERT THE VERY LAST AR-8724VCL-18 KREULOCK SCREW, IT SUNK BELOW THE DISTAL HOLE OF AN AR-8916VSR-03 VOLAR DISTAL RADIUS PLATE. THE SCREW BECAME STUCK IN THE PLATE AND WHEN SURGEON ATTEMPTED TO REMOVED THE SCREW, THE T8 SCREW DRIVER BENT. FINALLY, SURGEON HAS TO REMOVE ALL THE OTHER SCREWS AND FORCIBLY REMOVE THE LAST SCREW WHICH WAS STILL STUCK TO THE PLATE. A NEW PLATE WAS OPENED AND CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A RADIUS FRACTURE PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19257533 ↗
• MalfunctionSep 26, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916VSR-03 VOLAR DISTAL RADIUS PLATE APPEARED NOT TO HAVE A STOPPING POINT, AND WHEN THE SCREW WAS INSERTER, IT WENT THROUGH THE PLATE. THE CASE WAS COMPLETED USING A NEW PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 09/01/2023: THIS WAS DISCOVERED DURING A DISTAL RADIUS FRACTURE PROCEDURE. THE SURGEON REMOVED THE AR-8724V-18 LOW PROFILE VA LOCKING SCREW FROM THE PLATE AND TRIED TO INSERT A NEW ONE, WHICH HAD THE SAME RESULTS. THE SURGEON REMOVED AR-8724V-18 LOW PROFILE VA LOCKING SCREW THAT WENT THROUGH THE PLATED AND RE-IMPLANTED USING THE NEW AR-8916VSR-03 VOLAR DISTAL RADIUS PLATE TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 17816848 ↗