BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-DEVICE F/ZERO-P

    MDR report key: 3183114 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03575
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE BOTH DEVICES, THE AIMING DEVICE AND THE ZERO-P PASSED FUNCTIONAL TESTING. THE MALFUNCTION WAS NOT ABLE TO BE REPRODUCED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE TO CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT THE IMPLANT WAS NOT PROPERLY ATTACHED TO THE INSTRUMENT OR NOT ENOUGH PRESSURE WAS APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT CAME LOOSE FROM THE IMPLANT HOLDER AFTER BEING JAMMED AND CAUSED THE IMPLANT TO FALL ON THE FLOOR. A SECOND IMPLANT WAS AVAILABLE TO FINISH THE PROCEDURE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282700 AIM-DEVICE F/ZERO-P OVE SYNTHES GMBH T922516

    Patients

    Seq Age Sex Outcome Treatment
    1