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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867130876), received between Feb 15, 2018 and May 24, 2018 — classified as 2 injuries.

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

• InjuryMay 24, 2018Break

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT A SHOULDER PROCEDURE WHEN A VOLAR DISTAL RADIUS PLATE (AR-8916VNL-05, LOT: 10041406) WAS IMPLANTED. AT SOME POINT POST-OP, THE PLATE BROKE IN HALF. THE SURGEON DOES NOT BELIEVE THAT THE PATIENT HAD A FALL BUT HAS NOT SEEN THIS TYPE OF PLATE BREAK LIKE THIS BEFORE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE THE PLATE. FOLLOW-UP INVESTIGATION: THE FRACTURE WASN'T HEALED SO THE SURGEON IMPLANTED IMPLANTS FROM ANOTHER MANUFACTURER FOR THE REVISION. BOTH, THE ORIGINAL AND THE REVISION SURGERY WERE PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON. THE FOLLOWING SCREWS WERE EXPLANTED WITH THE PLATE, AR-8916VNL-05: AR-8724V-14, LOT: 194602 X2. AR-8724V-16, LOT: 189143 X2. AR-8724V-20, LOT: 197058 X2. AR-8935-14, LOT: 10147341 X1. AR-8935-16, LOT: 10083240 X1. AR-8935L-14, LOT: 204526 X3. AR-8935L-18, LOT: 202514 X1.

  Patient problems: No Information

  MAUDE report 7540118 ↗
• InjuryFeb 15, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHERE THE VOLAR DISTAL RADIUS PLATE WAS IMPLANTED. THE DISTAL RADIUS PLATE BROKE AT THE K-WIRE HOLE POST-SURGERY WHILE THE PATIENT WAS IN REHAB. A SECOND SURGERY WAS PERFORMED TO REMOVE THE PLATE. NO FURTHER DETAILS. FOLLOW-UP INVESTIGATION: THE SAME SURGEON PERFORMED BOTH, THE ORIGINAL SURGERY AND THE REVISION SURGERY. A SONOMA WRX-6470-G-S WAS IMPLANTED TO REPLACE THE BROKEN AR-8916VNL-05. THE SCREWS WERE REMOVED WITH THE PLATE AS WELL . PATIENT IS A FEMALE, (B)(6) AND WAS COMPLIANT WITH ALL POST-OP GUIDELINES.

  Patient problems: Failure of Implant

  MAUDE report 7273915 ↗