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NA SD351.719Recalls & reported problems

Synthes GmbH · DEPTH GAUGE EXTENSION TUBE WITH ANGLES · 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 10886982005540), received between Sep 11, 2023 and Sep 11, 2023 — 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.

  • MalfunctionSep 11, 2023Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SD DEPTH GAUGE WAS FOUND TO BE BROKEN. THE TANGS ON THE END OF THE ITEM HAVE BROKEN. IT IS UNKNOWN IF THERE WAS ANY PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE EXTENSION TUBE WITH ANGLES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17718856 ↗

Other GAUGE, DEPTH devices

All GAUGE, DEPTH devices →

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