Arthrex® AR-8973R-30-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867295216), received between Aug 5, 2020 and Sep 6, 2024 — classified as 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973R-30-130 ARTHREX RIGHT FIBULOCK NAIL TALONS WOULD NOT EXPAND OR ENGAGE WITH THE ACTUATION DRIVER. A NEW AR-8973R-30-130 ARTHREX RIGHT FIBULOCK NAIL WAS USED, AND THE ACTUATION DRIVER ENGAGED IMMEDIATELY. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED THREE MINUTES WITHOUT ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161842 ↗
• MalfunctionMay 2, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-8973R-30-130 FIBULOCK NAIL PROXIMAL TALONS ON THE FIBULAR NAIL DID NOT DEPLOY WHEN ENGAGED WITH THE ACTUATOR. WHEN THE SURGEON PLACED THE ACTUATOR INTO THE NAIL, IT NEVER CLICKED OR CONNECTED WITH THE IMPLANT BUT INSTEAD JUST SPUN IN PLACE. THE SURGEON REMOVED THE NAIL FROM THE FIBULA TO SEE IF IT WAS PLACED PROPERLY ON THE JIG, AND IF ANYTHING WAS BLOCKING THE ACTUATOR. THE IMPLANT WAS TIGHTLY SECURED, AND THERE WAS STILL NO ENGAGEMENT. THE FIBULOCK NAIL WAS REMOVED AND ANOTHER AR-8973R-30-130 FIBULOCK NAIL WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19229458 ↗
• InjuryAug 17, 2022Material Twisted/Bent

  ON 7/28/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973R-30-130 FIBULA NAIL HAS NO 60 DEGREE BEND. THE NAIL WAS STRAIGHT. THIS WAS DISCOVERED DURING A FIBULA FRACTURE PROCEDURE. THE NAIL WAS IMPLANTED BUT DID NOT FIT BECAUSE THERE WAS NO BEND. THE SURGEON REMOVED IT AND CLOSED THE CASE WITHOUT HAVING FIXATION ON THE FIBULA SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15242838 ↗
• MalfunctionJul 20, 2021Break

  IT WAS REPORTED PER THE SALES REP DURING AN ANKLE FRACTURE PROCEDURE THE DOCTOR DID NOT REAM DOWN TO THE RECOMMENDED DEPTH AND DURING INSERTION THE TIP OF THE NAIL BROKE. ALL WAS RETRIEVED. THE SURGEON REAMED FURTHER AND IMPLANTED ANOTHER LONGER NAIL AND THERE WAS NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196423 ↗
• InjuryJan 18, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED, THAT DURING AN ANKLE FRACTURE REPAIR PROCEDURE, DURING INSERTION OF THE AR-8972R-30-130 THE PROXIMAL TALONS OPENED PRIOR TO DEPLOYMENT WITH THE DRIVER. THE SURGEON TRIED TO TAP WITH THE IMPACTOR HOWEVER, STILL A LOT OF RESISTANCE. THE SURGEON REMOVED THE AR-8972R-30-130, USED THE WHITE HANDLED DRIVER TO DISENGAGED THE TALONS, UNTIL THEY WERE FLUSH WITH THE SHAFT. THE SURGEON INSERTED THE SAME AR-8972-30-130 AND THE SAME PROBLEM OCCURRED. THE AR-8972R-30-130 WAS LOGGED AND THE TALONS BROKE OFF. THE SURGEON REMOVED THE AR-8972-30-130 UNABLE TO RETRIEVE THE BROKEN TALON. THE SURGEON USED THE SAME INSERTION SITE AND COMPLETED THE CASE USING A DIFFERENT AR-8972R-30-130.

  Patient problems: Insufficient Information

  MAUDE report 11186228 ↗
• InjuryAug 5, 2020Break; Difficult to Remove

  IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION ANKLE FRACTURE FIBULA REPAIR THE NAIL WAS INSERTED PER TECHNIQUE, THE SURGEON DID NOT LIKE THE POSITION SO HE TRIED TO REMOVE IT. DURING THE REMOVAL IT BROKE AND THE END CAP REMAINED IN THE PATIENT. IT WAS OBSERVED THE TALONS OF THE IMPLANT WERE NOT OPEN. THE DOCTOR REPLACED IT WITH ANOTHER NAIL AND IT WAS IMPLANTED WITH NO ISSUES BUT A PORTION OF THE FIRST NAIL STILL REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED. THE DOCTOR AND THE PATIENT ARE PLANNING TO DO A REVISION TO REMOVE THE FIRST PARTIAL NAIL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10366844 ↗