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NA 324.101Recalls & reported problems

Synthes GmbH · TEMPORARY FIXATION PIN · 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 10705034769325), received between Jul 20, 2018 and Jul 20, 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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 20, 2018Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY. DURING THE SURGERY, AN EXTRACTION SCREWDRIVER AND THE TEMPORARY FIXATION PIN BROKE. BONE WAX WAS USED WITH VECTRA REMOVAL SCREW DRIVER TO COMPLETE THE SURGERY. THERE WAS A 15 MINUTES SURGICAL DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) TEMPORARY FIXATION PIN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7707125 ↗

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.