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NA SD357.403Recalls & reported problems

Synthes GmbH · 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/190MM · 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 10886982256829), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionMay 26, 2022Break; Break

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 TREATING A HIP FRACTURE USING TFNA SYSTEM, IT WAS OBSERVED THAT TWO (2) DRILL BIT DEVICES BROKE. THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14516509 ↗

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