BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-S

    MDR report key: 2831451 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01022
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE USED FOR TREATMENT. MANUFACTURING EVALUATION RESULTS REVEALED THE DEVICE WAS RECEIVED WITH THE TIP BROKEN OFF. THE RELEVANT DIMENSIONS WERE MEASURED AND WERE FOUND WITHIN THE SPECIFICATION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. DUE TO THE EVENT DESCRIPTION AND THE EVALUATION OF THE RETURNED DEVICE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. THE PRODUCT DEVELOPMENT RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. LOADING OF A HAND-HELD INSTRUMENT IS DICTATED BY FORCE EXERTED BY THE OPERATOR, NOT A FUNCTION OF DESIGN. EXCEEDING LOAD CAPACITY OF AN INSTRUMENT IS THEREFORE MISUSE. IMPOSSIBLE TO DETERMINE IF CAUSE OF FAILURE IS FROM INTENTIONAL MISUSE, PRODUCT DAMAGE OR EXCEEDING REASONABLE PRODUCT LIFE EXPECTANCY. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. LOADING OF A HAND-HELD INSTRUMENT IS DICTATED BY FORCE EXERTED BY THE OPERATOR, NOT A FUNCTION OF DESIGN. EXCEEDING LOAD CAPACITY OF AN INSTRUMENT IS THEREFORE MISUSE. IMPOSSIBLE TO DETERMINE IF CAUSE OF FAILURE IS FROM INTENTIONAL MISUSE, PRODUCT DAMAGE OR EXCEEDING REASONABLE PRODUCT LIFE EXPECTANCY.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE END OF THE FORCEP BROKE OFF. ALL PARTS WERE RETRIEVED, ANOTHER SET OF FORCEPS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER INCIDENTS DURING THE PROCEDURE, NO DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-S REDUCTION FORCEPS HTD SYNTHES GMBH 5005180

    Patients

    Seq Age Sex Outcome Treatment
    1