BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO

    MDR report key: 3082660 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02034
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION SHOWS THAT ONE OF THREE PRONGS IS INDEED BROKEN OFF. WE ACKNOWLEDGE THAT THIS IS A RATHER DELICATE DESIGN BUT WE SUPPOSE THAT SIMPLY TOO MUCH MECHANICAL FORCE WAS APPLIED AND CAUSED THE BREAKAGE. THE FILE HISTORY RECORDS WERE REVIEWED AND SHOWED CONFORMITY WITH THE MATERIAL- AND MANUFACTURING SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MEDICAL RECORD ID: (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED. THE TIP OF HOLDER FOR SET FOR BONE GRAFT HARVESTING DURING A LEFT HIP CORE DECOMPRESSION SURGERY BROKE. THE BROKEN TIP IS NOT AVAILABLE FOR EVALUATION. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185780 HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO HWX SYNTHES GMBH 2481029

    Patients

    Seq Age Sex Outcome Treatment
    1