BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 3003537 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10408
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE HANDLE BROKEN OFF. THE PRODUCT INVESTIGATION FOUND THE COMPLAINT TO BE INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION - FIXATION OF A BROKEN HIP, THE HANDLE ON THE COLLINEAR REDUCTION CLAMP SLIDING MECHANISM BROKE. THIS INCIDENT DID NOT IMPACT THE PATIENT. ALL OF THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITH NO EXTRA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87011 SLIDING MECHANISM HTD SYNTHES GMBH 1497185

    Patients

    Seq Age Sex Outcome Treatment
    1