BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDING INSERT F/AIMING ARM F/PF

    MDR report key: 3206309 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-04072
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    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. 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PERFORMED INVESTIGATION ACCORDING TO OUR MANUFACTURING DOCUMENTS SHOWS NO DEVIATION REGARDING TO OUR GUIDELINES. THE SAME IS TRUE FOR THE HARDENING PARAMETERS, WHICH ARE WITHIN THE REQUIRED TOLERANCES. UNFORTUNATELY WE CAN NOT ELICIT THE EXACT CAUSE, WHICH WAS LEADING TO THIS DAMAGE. IT ONLY CAN BE SUPPOSED THAT TO HIGH TORSION FORCES POSSIBLE IN CONNECTION WITH A NOT COMPLETED INSERTED APPLICATION WAS LEADING TO THIS RESULT. NO PRODUCT FAULT COULD BE DETECTED. DISPOSITION IS INDETERMINATE. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE INSTRUMENT DISSOLVES UNDER PRESSURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305155 LOCKING SLIDING INSERT F/AIMING ARM F/PF LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1