BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACT-HOLD-SLEEVE F/HIPPIN

    MDR report key: 2983226 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00679
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOWED CONFORMITY TO THE SPECIFICATIONS. A FUNCTIONAL TEST GOT PERFORMED AND SHOWED, THAT THE ARTICLES ARE IN WORKING ORDER LIKE THERE WERE TESTED BEFORE SHIPPING. THE INSPECTION OF ALL SIX ARTICLES SHOWED CONFORMITY TO THE SPECIFICATIONS. THESE ARTICLES ARE GOOD. WE ASSUME THAT THE WRONG SCREWDRIVER WAS USED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE EXTRACT-HOLDING SLEEVE FOR HIP PIN DOES NOT MEET THE STANDARD. NO FURTHER INFORMATION WAS AVAILABLE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88656 EXTRACT-HOLD-SLEEVE F/HIPPIN EXTRACT-HOLD-SLEEVE FZX SYNTHES GMBH 7754465

    Patients

    Seq Age Sex Outcome Treatment
    1