NA 04.032.100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982094858), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM POLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A SYNTHES TFN FOR TROCHANTERIC FRACTURES WAS IMPLANTED AFTER A SUBTROCHANTERIC FRACTURE. ON (B)(6) 2019, AN X-RAY WAS PERFORMED DURING A FOLLOWUP VISIT THAT FOUND SUSPECTED DAMAGE TO THE NAIL. 16 DAYS LATER, THE LEG WITH THE IMPLANT BROKE FOR THE SECOND TIME. ON (B)(6) 2019 THE PATIENT EXPERIENCED COLLAPSE, AND ON (B)(6) 2019 UNDERWENT A PROCEDURE TO REMOVE THE BROKEN TFN NAIL AND TO INSERT A LONG FEMORAL NAIL AS A REPLACEMENT. THIS REPORT IS FOR AN 11.0MM TI TROCH FIXATION NAIL SCREW/100MM ¿ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Anaphylactic Shock; Loss of Range of Motion; Necrosis; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema; Unspecified Infection

  MAUDE report 16689384 ↗