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NA 397.023Recalls & reported problems

Synthes GmbH · IMPACTOR, CRESCENT 9MM X 20MM HEAD · 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 10705034778297), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

  • Contamination /Decontamination Problem1

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.

  • MalfunctionFeb 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE LOANER SET WHICH CONTAINS INSTRUMENTS WITH FERROZELL HANDLES CANNOT BE STERILIZED BY THE STERILIZATION DEPARTMENT. THE INSTRUMENTS ARE OTHERWISE IN PERFECT WORKING ORDER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE IMPACTOR, CRESCENT 9MM X 20MM HEAD. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9687059 ↗

Other IMPACTOR devices

All IMPACTOR devices →

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