NA 03.233.011SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982299789), received between Mar 7, 2023 and Dec 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE FOR A TIBIAL SHAFT FRACTURE, BOTH THE REAMER AND ROD BROKE AT THE SAME LOCATION AFTER DIFFICULT REAMING, NECESSITATING AN ADDITIONAL SKIN INCISION FOR REMOVAL. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A DIFFERENT INSTRUMENT, WITH NO SURGICAL DELAY. IMAGING CONFIRMED NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. THE EVENT REQUIRED A CHANGE IN SURGICAL APPROACH BUT DID NOT RESULT IN DEATH OR ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23828861 ↗
• MalfunctionMar 7, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  HOLD JS 3.15.23. DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, WHEN COUPLING THE SLIDING GUIDE WITH DIFFERENT NOZZLES, NONE COUPLED BECAUSE THE THREADS WERE COMFORTABLE. LIKEWISE, WHEN COUPLING THE HANDLE TO THE SLIDING GUIDE, IT DID NOT ENGAGE. AT THE TIME OF DRILLING WITH THE TREPHINE, IT WAS BURNED ON ITS EDGES, AND AT THE TIME OF WASHING IT WAS IMPOSSIBLE TO REMOVE. THIS REPORT INVOLVES ONE THREADED CONICAL BOLT FOR 9MM-12MM UNIV FEMORAL NAILS. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497431 ↗