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DCP 322.32Recalls & reported problems

Synthes GmbH · 3.5MM DCP® DRILL GUIDE NEUTRAL & LOAD · 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 10886982190512), received between Apr 17, 2020 and Apr 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1
  • Material Twisted/Bent1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionApr 17, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT THE 3.5MM DCP DRILL GUIDE IS NOT WORKING PROPERLY DUE TO WEAR AND TEAR. ITEM WAS BECOMING LOOSE AND NOT TIGHTENING PROPERLY WHEN IT WAS PLACED BACK TOGETHER AFTER A CASE. ITEM WAS DISCARDED AND NO PICTURE TAKEN. NO SURGICAL DELAY OR INTRA-OP ISSUES. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 3.5MM DCP® DRILL GUIDE NEUTRAL & LOAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9972123 ↗

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