BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR-HOLDER W/O INSERT

    MDR report key: 3139288 · Received May 31, 2013

    Report

    Report Number
    8030965-2013-02536
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    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. AN EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT THE SCREW HOLDER WERE FOUND TO BE IN CONFORMANCE. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE CAUSE OF THE INSTRUMENT FALLING APART COULD BE DUE TO MECHANICAL OVERLOADING DURING APPLICATION. NO PRODUCT FAULT COULD BE DETECTED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: DZJ. THE PRODUCT WAS RETURNED AND IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING AN OPERATION THE INSTRUMENT SUDDENLY FELL APART. NO HARM TO THE PATIENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241230 SCR-HOLDER W/O INSERT DZI SYNTHES GMBH 8120898

    Patients

    Seq Age Sex Outcome Treatment
    1