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NA 310.68Recalls & reported problems

Synthes GmbH · 3.5MM CANNULATED DRILL BIT/QC 160MM · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982186911), received between Feb 25, 2021 and Apr 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure to Cut3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

  • MalfunctionApr 26, 2022Failure to Cut; Failure to Cut

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE CHECKING THE DRILL BEFORE IT WAS ENTERED TO THE SET, THE LOGISTIC MAN NOTICED THAT THE DRILL IS NOT CANNULATED FROM BOTH SIDES. THIS COMPLAINT INVOLVES ONE (1) DEVICE 3.5MM CANNULATED DRILL BIT QC 160MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14209850 ↗
  • MalfunctionDec 24, 2021Failure to Cut; Failure to Cut

    IT WAS NOTED THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13085376 ↗
  • MalfunctionFeb 25, 2021Failure to Cut; Failure to Cut

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGICAL PROCEDURE, THE DRILL GRADUALLY LOST ITS ABILITY TO DRILL. AND IT WAS OBSERVED THAT ITS TIP WAS SMOOTH WITHOUT AN EDGE. THE SURGERY WAS COMPLETED WITHOUT DELAY. THE PATIENT STATUS WAS SATISFACTORY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - PLATES. THIS IS REPORT 1 OF 1 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11382074 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.