BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIX-SLEEVE

    MDR report key: 2993699 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-00493
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    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. 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 USED FOR TREATMENT AND NOT DIAGNOSIS. ISIMAC MACHINE COMPANY MANUFACTURED THE DRILL STOP, PART 357.405, AND LOT NUMBER 6623811. THE MATERIAL OF THE HOUSING AND THE BUTTON WERE CONFIRMED TO BE CORRECT. FUNCTIONAL TESTING WAS PERFORMED USING GAGE GT026298 AND THE DRILL STOP PASSED THE FUNCTIONAL TEST. THE MATERIAL WAS TESTED AND CONFORMED TO SPECIFICATIONS. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING AT SYNTHES INCOMING INSPECTION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT ON (B)(6) 2013, THE FIX-SLEEVE WOULD MOVE BACKWARDS IF IT WAS MINIMALLY TILTED. IT WOULD HOLD WHEN POSITIONED STRAIGHT, BUT IF IT WAS TILTED AT ALL, IT WOULD MOVE BACKWARDS DURING DRILLING. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98107 FIX-SLEEVE FZX SYNTHES MONUMENT 6623811

    Patients

    Seq Age Sex Outcome Treatment
    1