Arthrex® AR-8956C-45TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867055728), received between Nov 15, 2018 and Jun 6, 2024 — classified as 2 injuries, 1 malfunction.

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 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.

• InjuryJun 6, 2024Break; Break

  ON 5/9/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8956C-45T BONE TAP, CANNULATED, 4.5 MM, BROKE DURING A 5TH METATARSAL FRACTURE. WHEN THE SURGEON TURNED THE AR-8956C-45T BONE TAP COUNTERCLOCKWISE, IT BROKE, SNAPPING THE ENTIRE "GOLD" PORTION OF THE TAP IN THE SHAFT OF THE METATARSAL. THEY WERE ABLE TO GET IT OUT WITH A NON-ARTHREX HARDWARE REMOVAL SET. THIS WAS DISCOVERED DURING A METATARSAL FRACTURE PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/20/2024: ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS DELAYED 25 MINUTES TO RETRIEVE THE END OF THE TAP FROM THE CANAL OF THE 5TH METATARSAL. THE PATIENT HAD TO HAVE LONGER OR TIME, MORE ANESTHESIA, AND A LARGER INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475865 ↗
• MalfunctionJan 3, 2023Break

  IT WAS REPORTED ON 12/14/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8956C-45T BONE TAP SNAPPED OFF WHILE TRYING TO BACK OUT OF THE BONE. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 16086684 ↗
• InjuryNov 15, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A 5TH METATARSAL FX PROCEDURE, THE SURGEON USED A 4.5MM CANNULATED BONE TAP, AR-8956C-45T TO TAP THE METATARSAL. WHEN REMOVING THE BONE TAP, THE SHAFT BROKE AND THE THREADED PORTION OF THE BONE TAP REMAINED IN THE INTERMEDULLARY CANAL. ADDITIONAL INFORMATION RECEIVED 10/24/2018: NO ATTEMPTS WERE MADE TO REMOVE THE DEVICE HOWEVER, THE REP AND SURGEON DISCUSSED WAYS TO GET IT OUT. THEY SPOKE TO THE FAMILY, BUT NEVER ATTEMPTED TO REMOVE IT. THE PATIENT WAS CLOSED AND SPLINTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8074226 ↗