NA 310.634Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982186843), received between Sep 25, 2017 and May 17, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT GOT CAUGHT INSIDE THE THREADED GUIDE. UNKNOWN IF THERE WERE ANY PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø4.3 CANN L200 W/QUICK-COUPLE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950028 ↗
• MalfunctionFeb 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT THERE WAS STILL DIRT IN THE TWO (2) CANNULATED DRILL BITS. IT WAS FOUND BEFORE THE PROCEDURE, BEFORE STERILIZATION IN THE HOSPITAL. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) 4.3MM CANNULATED DRILL BIT/QC 200MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387585 ↗
• MalfunctionFeb 9, 2023Failure to Cut; Failure to Cut

  THE TIMING OF THE REPORTED EVENT WAS INTRA-OPERATIVE. THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335993 ↗
• MalfunctionJun 16, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BITS LOST EDGE IN THE DURING SURGERY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 4.3MM CANNULATED DRILL BIT/QC 200MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010161 ↗
• MalfunctionSep 25, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY A SURGEON WAS PLACING THE SCREWS ON THE HEAD OF THE FEMUR WHEN THE SCREWDRIVER BROKE. ALSO, AT THE SAME TIME WHEN THE SURGEON USED THE DRILL BIT THIS ALSO BROKE, GENERATING A DELAY OF TWO (2) HOURS IN THE SURGERY DUE TO THE CHANGE OF ANESTHESIA PROCEDURE. THERE ARE 2 DEVICES IN THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892345 ↗