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NA 389.802Recalls & reported problems

Synthes GmbH · THREADED DRILL GUIDE · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034776736), received between Mar 19, 2021 and Mar 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 19, 2021Material Integrity Problem; Material Integrity Problem

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREADED GUIDE BROKE DURING SURGERY. NO FRAGMENTS WERE GENERATED, AND THERE WERE NO SURGERY DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) THREADED DRILL GUIDE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11527712 ↗

Other Guide, surgical, instrument devices

All Guide, surgical, instrument devices →

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