BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLD-SL F/SPIRIT SLOTTED SHORT F/CLICKX

    MDR report key: 2990888 · Received March 6, 2013

    Report

    Report Number
    8030965-2013-00761
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE LOCKING PINS CAME INDEED OFF. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION AT THE TIME OF MANUFACTURING. DUE TO REPEATED WORLDWIDE COMPLAINTS A CAPA (B)(4) WAS INITIATED IN ORDER TO ELIMINATE SUCH PROBLEMS IN FUTURE. OUR MANUFACTURING ENGINEERS DECIDED TO EXCHANGE THE DESIGN OF THE LOCKING PIN IN THE AREA OF THE LASER WELDING. PLEASE NOTE THAT THESE ARTICLES WERE MANUFACTURED ACCORDING TO THE OLD DESIGN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 REPORTEDLY TWO HOLDING SLEEVES MALFUNCTIONED. ONE OF THE DEVICES IS UNABLE TO HOLD THE SCREW. THE OTHER DEVICE IS BROKEN. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95776 HOLD-SL F/SPIRIT SLOTTED SHORT F/CLICKX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 3101991

    Patients

    Seq Age Sex Outcome Treatment
    1