BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS

    MDR report key: 14855381 · Received June 28, 2022

    Report

    Report Number
    MW5110582
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 24, 2022
    Manufacturer
    DUPUY SYNTHES / DUPUY ORTHOPAEDICS
    Product Code
    HYA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE OPERATIVE PROCEDURE THE SURGEON WAS USING REDUCTION FORCEPS TO REDUCE THE FRACTURE. THE TIP OF THE FORCEPS BROKE WHILE ATTEMPTING TO GAIN REDUCTION. THIS HAPPENED TWO TIMES WITH 2 FORCEPS. THE BROKEN TIPS OF BOTH FORCEPS WERE IMMEDIATELY RECOVERED. AN XRAY WAS TAKEN TO CONFIRM ALL PIECES WERE RECOVERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846172 FORCEPS REDUCTION FORCEPS HYA DUPUY SYNTHES / DUPUY ORTHOPAEDICS
    846173 FORCEPS REDUCTION FORCEPS HYA DEPUY SYNTHES / DEPUY ORTHOPAEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other