BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEND/CUT-PLIERS

    MDR report key: 3231242 · Received July 17, 2013

    Report

    Report Number
    8030965-2013-04387
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE ADDITIONAL EVALUATION ARE AS FOLLOWS: THE INVESTIGATION OF THE DISPUTED FORCEPS SHOWED THAT A CARBIDE INSERT THE WIRE CUTTER IS BROKEN. THIS LOSS IS DUE TO THE USE OF EXCESSIVE MECHANICAL STRESS IN THIS AREA. WE SUSPECT THAT THE WIRE WAS PASSED UNFAVORABLE AND THUS EXCESSIVE MECHANICAL FORCES OCCURRING IN THE REGION OF THE TIP. A REVIEW OF THE PRODUCTION DOCUMENTS AND THE VISUAL INSPECTION OF PLIERS SHOWED NO EVIDENCE OF A PRODUCT FAILURE. WE CAN NOT DETERMINE AN ACCURATE CAUSE OF THE OUTBREAK OF THE CARBIDE INSERT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CUTTING CLAMP BROKE OFF DURING A PROCEDURE ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332226 BEND/CUT-PLIERS HTC SYNTHES GMBH T974450

    Patients

    Seq Age Sex Outcome Treatment
    1