Arthrex® AR-8973R-30-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295230), received between Aug 10, 2023 and Jun 5, 2025 — classified as 3 malfunctions.

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

• MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/13/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8973R-30-180 ARTHREX FIBULOCK NAIL HAD AN ISSUE AFTER BEING INSERTED. DURING THE PROCEDURE, THE DEVICE WAS INSERTED, BUT WHEN ATTEMPTING TO INSERT THE PRODUCT A LITTLE DEEPER BEFORE OPENING THE TALON, THE TALON COULD NOT BE FULLY CLOSED. AS A RESULT, FURTHER INSERTION WAS STOPPED, AND THE DEVICE WAS REMOVED. A REPLACEMENT AR-8973R-30-180 ARTHREX FIBULOCK NAIL WAS USED INSTEAD. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151310 ↗
• MalfunctionApr 18, 2025Break; Break

  ON 03/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973R-30-180 ARTHREX FIBULOCK NAIL BROKE AT THE TIP OF WHERE THE TALONS DEPLOY DURING THE BEGINNING INSERTION OF THE NAIL. THE TALONS WERE COMPROMISED AND COULD NOT BE DEPLOYED PROPERLY. THERE WAS AN INCREASE IN CASE TIME, AND ANESTHESIA WAS INCREASED BY 15-20 MINUTES. THE BROKEN IMPLANT PORTION WAS LEFT INSIDE THE PATIENT. THE BROKEN PIECE WAS ADVANCED UP THE CANAL TO MAKE SURE THAT THE FINAL IMPLANT COULD BE USED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21864679 ↗
• MalfunctionAug 10, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973R-30-180 FIBULOCK® NAIL BENT OVER SIDEWAYS. THIS OCCURRED DURING AN OPEN TIBIAL FRACTURE ON (B)(6) 2023, AFTER REAMING THE NAIL WAS INSERTED AND AFTER INSERTING THE PLATE AND THE TIP OF THE NAIL WAS BENT OVER SIDEWAYS THE DEVICE WAS PULLED OUT AND THE CASE WAS COMPLETED USING A AR-8973R-30-130. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497518 ↗