Arthrex® AR-8973-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867302044), received between Aug 11, 2020 and May 6, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Defective Device; Defective Device

  ON 8/30/2021 IT WAS REPORTED BY SALES REP VIA EMAIL THAT AR-8973-07 FIBULOCK DRILL GUIDE SLEEVE WILL NOT FIT INTO THE FIBULOCK JIG THE WAY IS SUPPOSED TO, CAUSING RESISTANCE. SURGEON WAS ABLE TO PLATE ANKLE REGARDLESS, SUCCESSFULLY COMPLETING PROCEDURE. NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247826 ↗
• InjuryAug 11, 2020Component Missing; Failure to Align

  IT WAS REPORTED THAT 6/307/24/20, DURING AN ORIF ANKLE PROCEDURE WITH FIBULOCK NAIL, THE FIBULOCK TARGETING GUIDES AND ASSOCIATED GUIDES (AR-8973-01, AR-8973-07, AR-8973-08) WERE MISSING THE FIBULOCK NAIL. THIS RESULTED IN THE SCREW BEING INSERTED IN THE FIBULA TO THE LEFT OF THE NAIL, BUT NOT IN THE FIBULOCK NAIL ITSELF, THUS COMPROMISING THE REDUCTION AND ALIGNMENT OF THE INTERNALLY FIXATED FIBULA. THESE SAME THREE DEVICES WERE ALSO USED IN A PROCEDURE ON (B)(6) 20 (CASE (B)(4)) HAVING THE SAME ISSUE/RESULT. THE DEVICES WILL BE RETURNED FOR EVALUATION UNDER CASE (B)(4) AND EVALUATION WILL BE APPLIED TO BOTH INCIDENTS/CASE NUMBERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10390753 ↗
• InjuryAug 11, 2020Component Missing; Failure to Align

  IT WAS REPORTED THAT (B)(6) 2020, DURING AN ORIF ANKLE PROCEDURE WITH FIBULOCK NAIL, THE FIBULOCK TARGETING GUIDES AND ASSOCIATED GUIDES WERE MISSING THE FIBULOCK NAIL. THIS RESULTED IN THE SCREW BEING INSERTED IN THE FIBULA TO THE LEFT OF THE NAIL, BUT NOT IN THE FIBULOCK NAIL ITSELF, THUS COMPROMISING THE REDUCTION AND ALIGNMENT OF THE INTERNALLY FIXATED FIBULA. IT WAS REPORTED THAT (B)(6) 2020, DURING AN ORIF ANKLE PROCEDURE WITH FIBULOCK NAIL, THE FIBULOCK TARGETING GUIDES AND ASSOCIATED GUIDES (AR-8973-01, AR-8973-07, AR-8973-08) WERE MISSING THE FIBULOCK NAIL. THIS RESULTED IN THE SCREW BEING INSERTED IN THE FIBULA TO THE LEFT OF THE NAIL, BUT NOT IN THE FIBULOCK NAIL ITSELF, THUS COMPROMISING THE REDUCTION AND ALIGNMENT OF THE INTERNALLY FIXATED FIBULA. THESE SAME THREE DEVICES WERE ALSO USED IN A PROCEDURE ON (B)(6) 2020 (CASE (B)(4)) HAVING THE SAME ISSUE/RESULT. THE DEVICES WILL BE RETURNED FOR EVALUATION UNDER CASE (B)(4) AND EVALUATION WILL BE APPLIED TO BOTH INCIDENTS/CASE NUMBERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10390607 ↗