NA 04.033.965SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982272324), received between Sep 28, 2020 and Aug 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO A GUNSHOT WOUND WITH A NON DISPLACED BASALAR NECK FRACTURE. THE PATIENT HAD SUFFERED A GUNSHOT WOUND TO THE HIP WITH A NON DISPLACED BASALAR NECK FRACTURE THAT EXTENDED INTO THE TROCHANTERIC AREA. THE SURGEON HAD ORIGINALLY PLANNED TO GO WITH A TFNA, AND ELECTED TO GO WITH A FEMORAL RECON NAIL BECAUSE OF THE PATIENTS' SMALLER STATURE AND AGE. I ADVISED THAT THE FRN WAS NOT INDICATED FOR TROCHANTERIC TYPE FRACTURES, BUT ULTIMATELY THE SURGEON ELECTED TO USE THE NAIL. DURING THE CASE, THE 3.2 GUIDE PIN FOR THE RECON SCREW MISSED THE NAIL ON INITIAL ENTRY; HOWEVER IT WAS DETERMINED THAT SOFT TISSUE WAS BINDING ON THE SLEEVE. THE SLEEVES WERE READJUSTED, THE GUIDE PINS AND SCREWS WERE INSERTED PROPERLY. ULTIMATELY THERE WERE NO ALLEGATIONS AGAINST THE DEVICES OR ADVERSE EVENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1. THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 340MM / LEFT - STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318339 ↗
• MalfunctionSep 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2020: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A FEMORAL RECON NAIL PROCEDURE, THE UNKNOWN SCREWS AND THE UNKNOWN DRILL BIT HAVE MISSED THE UNKNOWN NAIL. THE CASE TURNED OUT FINE. IT WAS THE REPORTED THAT THE SUSPECTED DEVICES WERE THE RADIOLUCENT INSERTION HANDLE AND THE RADIOLUCENT AIMING ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS A MINOR SETBACK WITH THE UNKNOWN DRILL MISSING AS THE OUTCOME OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PROTECTION SLEEVE(PART# 03.010.075, LOT# PE03465, QUANTITY: 1), PROTECTION SLEEVE(PART# 03.010.075, LOT# PE03466, QUANTITY: 1), DRILL SLEEVE (PART# 03.010.076, LOT#PE03467, QUANTITY: 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594504 ↗