BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLD-SL F/SPIRIT SLOTTED SHORT F/CLICKX

    MDR report key: 3183152 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03705
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE LOCKING PINS INDEED CAME OFF. OUR ENGINEERS DECIDED TO ENHANCE THE DESIGN OF THE LOCKING PIN IN THE AREA OF THE LASER WELDING. THE INSTRUMENTS WERE STILL MANUFACTURED ACCORDING TO THE OLD DESIGN. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PINS ARE MISSING IN THE ATTACHMENTS OF THE HOLDING SLEEVES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282707 HOLD-SL F/SPIRIT SLOTTED SHORT F/CLICKX LXH SYNTHES GMBH 3101991

    Patients

    Seq Age Sex Outcome Treatment
    1