NA 03.010.115Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067869), received between Jun 1, 2018 and Jul 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE GUIDE WIRE WAS EMBEDDED WITH THE CANNULATED DRILL BIT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM GUIDE WIRE 290MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19732203 ↗
• MalfunctionJul 10, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6), AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2019, DURING DECONTAMINATION PROCESS, A GUIDEWIRE WAS FOUND DISTORTED OR CURVED. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.2 MM GUIDE WIRE 290 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8775336 ↗
• MalfunctionOct 15, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON RECEIPT OF ORDER, IT WAS DISCOVERED THAT A GUIDE WIRE WAS BENT AND QUITE CURVED THAT SUPPOSED TO BE STRAIGHT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.2MM GUIDE WIRE 290MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7966775 ↗
• MalfunctionJun 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED DURING A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) PROCEDURE ON AN UNKNOWN DATE, THE DRILL GUIDE WAS WORN OUT AND THE DRILL BIT WAS STARTING TO STICK WHEN PASSING THROUGH IT. THE SURGEON DID COMPLAIN ABOUT IT NOT PASSING THROUGH SMOOTHLY AS IT SHOULD. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL TIME DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANTICIPATED. CONCOMITANT DEVICE REPORTED: CANNULATED DRILL BIT (PART# 351.27, LOT# UNKNOWN, QTY 1). THIS REPORT IS FOR ONE (1) 3.2MM GUIDE WIRE 290MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560709 ↗