BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDING INSERT F/AIMING ARM F/PF

    MDR report key: 3253071 · Received July 29, 2013

    Report

    Report Number
    8030965-2013-04412
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED LOCKING SLIDING APPLICATION WAS SENT TO OUR RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR FURTHER INVESTIGATION. THERE IT HAS UNDERGONE A FUNCTION CONTROL. NO DEVIATIONS WERE FOUND. IT WAS NOT POSSIBLE TO REPEAT THE FAILURE. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPS BECAME DISENTANGLED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353029 LOCKING SLIDING INSERT F/AIMING ARM F/PF HWE SYNTHES GMBH 8205871

    Patients

    Seq Age Sex Outcome Treatment
    1