BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE PELVIC SYSTEM RED

    MDR report key: 3003414 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10429
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO 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 MFG INVESTIGATION REVEALED THE RIVET IS MISSING. THE INSTRUMENT CORRESPONDS TO DRAWINGS AND PROCESSES AT THE TIME OF MFR. ALL PARTS WERE NOT RETURNED TO COMPLETE THE INVESTIGATION. IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ORIF OF ACETABULUM, THE RIVET ON THE REDUCTION FORCEPS HOLDING THE CLAMP BROKE. SURGEON WAS UNABLE TO REDUCE WITH THIS INSTRUMENT AND SELECTED ANOTHER CLAMP TO COMPLETE THE PROCEDURE. NO FRAGMENTS BROKE INTO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87186 LOW PROFILE PELVIC SYSTEM RED HTD SYNTHES GMBH T9831268

    Patients

    Seq Age Sex Outcome Treatment
    1