NA 04.033.973SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982272362), received between Mar 31, 2020 and Jun 30, 2020 — 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.

• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN).

  Patient problems: Discomfort; No Code Available

  MAUDE report 10214417 ↗
• InjuryMar 31, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO THE BROKEN GREATER TROCHANTER FEMORAL RECON NAIL (FRN). THE PATIENT WAS IMPLANTED WITH DEPUY SYNTHES FEMORAL RECON NAIL AND ZIMMER BIOMET NCB PLATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE REPORTED EVENT OF POSTOP NAIL BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT OF BROKEN SCREWDRIVER AND DRIVING CAP . CONCOMITANT DEVICES REPORTED: TI RECON SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM/TI CANN FRN/GT 420MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9907551 ↗