NA 312.160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034768908), received between Jun 11, 2018 and Feb 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE K-WIRE WAS NOT RELEASED ENOUGH WHILE THE K-WIRE WAS ADVANCING. THE DRILL WAS PUSHED OVER THE DRILL GUIDE, CAUSING THE SPRING TO BREAK. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF ABOUT 10 MINUTES. THE PROCEDURE WAS CONTINUED WITH A DIFFERING TECHNIQUE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.25MM DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351095 ↗
• MalfunctionNov 11, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHEN THE SCRUB NURSE INSERTED THE GUIDEWIRE INTO THE DRILL SLEEVE, THE GUIDEWIRE GOT STUCK. THE SCRUB NURSE COULDN¿T PULL THE WIRE OUT AND SNAPPED OFF BOTH ENDS, LEAVING THE REST OF THE GUIDEWIRE STUCK INSIDE THE SLEEVE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE SPIRAL OF THE HANDLE WAS BROKEN, FRAGMENT WAS RETURNED. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED AS REPORTABLE ON NOVEMBER 8, 2022. THIS REPORT IS FOR ONE (1) 1.25MM DRILL SLEEVE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781212 ↗
• MalfunctionJun 11, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SLEEVE COVERING THE GUIDE WIRE BROKE. MOST OF THE SLEEVE FELL AWAY, WHILE A SMALL PART OF IT REMAINED INTACT TO THE DEVICE. THE DOCTOR CONTINUED USING THE DEVICE WITHOUT THE SLEEVE. THE DEVICE IS NOT USED FREQUENTLY AND HAD NOT BEEN IN USE RECENTLY, PRIOR TO THE INCIDENT. THE PRODUCT WAS RETURNED TO THE COMPANY'S WAREHOUSE AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED DELAYS OR COMPLICATIONS. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.25MM DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7587658 ↗