Arthrex® AR-8941KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888867051840), received between Jan 10, 2018 and Mar 7, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 3/24/2025: THERE WAS NO DELAYED IN THE CASE, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21548837 ↗
• InjuryMay 15, 2019Break; Difficult to Remove; Component Missing

  IT WAS REPORTED DURING A LISFRANC PROCEDURE, THE AR-8941KT THREADED GUIDEWIRE WITH TROCAR TIP WAS USED AS PROVISIONAL POINT OF FIXATION. AS THE SURGEON REMOVED THE GUIDEWIRE, IT CAME OUT MISSING THE THREADED TIP. THE SURGEON DECIDED TO LEAVE THE TIP IN THE BONE, AS IT WAS MID-SHAFT AND NOT CAPABLE OF MIGRATION. ADDITIONAL INFORMATION RECEIVED ON 05/15/2019: THE AGENCY CONFIRMED THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN. THE REP STATED THE SURGEON USED MULTIPLE INSTRUMENTS IN ATTEMPT TO EXTRACT THE BROKEN FRAGMENT, BUT THE FRAGMENT WAS BURIED IN THE BONE MIDSHAFT AND COULD NOT BE RETRIEVED. THE SURGEON CONCLUDED THAT THERE WAS NO CHANCE OF MIGRATION, AND THAT RETRIEVING THE PIECE WOULD CAUSE MORE HARM TO THE PATIENT THEN LEAVING IT IMPLANTED. THE REMAINING SHAFT OF THE GUIDEWIRE WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 8611789 ↗
• InjuryApr 18, 2018Break; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT WHILST IMPLANTING A CANNULATED SCREW, THE TIP OF APPROXIMATELY 5 MM FROM A 1.6 MM K WIRE BROKE-OFF IN THE PATIENT'S BONE. THE SURGEON ASSESSED THE SITUATION AND DECIDED THAT IT WOULD BE IN THE PATIENT'S BEST INTEREST TO LEAVE THE TIP IN THE BONE AS IT WOULD CAUSE MORE DAMAGE TO REMOVE THE FRAGMENT. PERFORMED SURGERY WAS A TRIPLE ANKLE FUSION. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE ANYWAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7439309 ↗
• InjuryJan 10, 2018Break

  IT WAS REPORTED THAT DURING A MPFL/ TIBIAL TUBERCLE OSTEOTOMY PROCEDURE, THE TIP OF THE THREADED GUIDE PIN BROKE-OFF INTO THE TIBIA WHILE THE SURGEON WAS PLACING IT ACROSS THE OSTEOTOMY FOR 4.5 MM LPS FIXATION. THE SURGEON MADE NO ATTEMPT TO RETRIEVE THE TIP OF THE PIN AND THE TIP WAS LEFT IN THE PATIENT. PATIENT IS A FEMALE, (B)(6). FOLLOW-UP INVESTIGATION: X-RAYS WERE TAKEN TO CONFIRM DEVICE LOCATION. DEVICE TIP IS EMBEDDED IN THE TIBIAL TUBERCLE. NO PICTURES WERE AVAILABLE. THE REMAINING PORTION OF THE GUIDE PIN WAS DISCARDED AND IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 7178414 ↗