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LC-DCP 323.45Recalls & reported problems

Synthes GmbH · 4.5MM LC-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 10886982190833), received between Oct 5, 2020 and Oct 5, 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

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.

  • MalfunctionOct 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHEN USING THE DRILL GUIDE DURING A HUMERUS FRACTURE PROCEDURE, THE GREEN END KEPT SLIPPING OUT. THE SURGEON TRIED ROTATING THE GREEN AND YELLOW PIECES BUT IT WOULD NOT HOLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 4.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10627112 ↗

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