BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 1861971 · Received October 5, 2010

    Report

    Report Number
    3005039508-2010-00017
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - WE CONFIRMED THE DRIVER TIP WAS BROKEN PER THE FIELD REPORT. CONCLUSION - WE CONCLUDED THAT THE FAILURE WAS METAL FATIGUE, VIA TESTING OF FOUR PARTS FROM THE SAME LOT.

    Description of Event or Problem · 1

    WE RECEIVED AN E-MAIL FROM THE SALES REP WHO STATED, WE BROKE A SCREW DRIVER (HCS-056-25) ON (B)(6), DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGNS HCS-056-25 1067041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention