NA 04.033.171SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982271716), received between Aug 15, 2018 and May 5, 2023 — classified as 2 injuries.

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

• InjuryMay 5, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT NEEDED A REVISION SURGERY DUE TO NAIL BREAKAGE AT THE POINT OF THE PROXIMAL TRANSVERSE SCREW HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2023. A DIFFERENT IMPLANT WAS PLACED IN THE REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 11MM / TI CANN FRN / GT 400MM / LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16875779 ↗
• InjuryAug 15, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN INTRAMEDULLARY (IM) NAIL PROCEDURE. THE SURGEON REAMED THE FEMORAL CANAL, FINISHING WITH A 12.5 MM REAMER AND INSERTED AN 11 MM LEFT RECON NAIL. AS THE SURGEON INSERTED THE NAIL, IT BECAME VERY TIGHT AT THE LEVEL OF THE FRACTURE SITE AND WAS NOT ABLE TO ADVANCE THE NAIL ANY FURTHER. THE NAIL EXTRACTION ROD WAS ATTACHED TO THE DRIVING CAP AND ATTEMPTED TO REMOVE THE NAIL. THE SURGEON WAS ABLE TO BACK THE NAIL OUT SLIGHTLY BUT NOT ALL THE WAY. THEN TRIED TO DRIVE THE NAIL IN AGAIN BUT AFTER SEVERAL STRIKES OF THE MALLET ON THE DRIVING CAP, THE DRIVING CAP BROKE. THE THREADS OF THE DRIVING CAP BROKE OFF INSIDE OF THE INSERTION HANDLE SO THAT ANOTHER DRIVING CAP COULD NOT BE USED. THEN SURGEON REMOVED THE INSERTION HANDLE FROM THE NAIL AND ATTACHED THE NAIL EXTRACTION BOLT TO THE NAIL AND WAS ABLE TO REMOVE THE NAIL. AFTER THE NAIL WAS REMOVED, THE SURGEON DECIDED TO GO DOWN TO A 10 MM RECON NAIL AND WAS ABLE TO INSERT THE NAIL BY HITTING THE INSERTION HANDLE WITH THE MALLET. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES R

  Patient problems: No Code Available

  MAUDE report 7785906 ↗