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NA 312.67Recalls & reported problems

Synthes GmbH · 6.5MM/3.2MM DOUBLE DRILL SLEEVE · 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 10886982187864), received between Jul 6, 2018 and Jul 6, 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.

  • MalfunctionJul 6, 2018Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2018, WHILE AT STERILE PROCESSING, A 6.5MM CANNULA WAS NOTICED TO HAVE BROKEN OFF FROM THE 3.2/6.5MM DRILL GUIDE UPON SET ASSEMBLY BY A STAFF MEMBER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 6.5MM/3.2MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 7666927 ↗

Other Guide, surgical, instrument 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.