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NA 399.62Recalls & reported problems

Synthes GmbH · GOUGE 10MM-STANDARD & STRAIGHT · 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 10886982202994), received between Oct 4, 2018 and Oct 4, 2018 — 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 Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 4, 2018Break; Break

    IT WAS REPORTED THAT UPON RECEIPT OF THE ORDER ON (B)(6) 2018, IT WAS NOTED THAT THE TIP OF A GOUGE 10MM-STANDARD & STRAIGHT WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) GOUGE 10MM-STANDARD & STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 7936025 ↗

Other GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY devices

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