BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACT ADJUSTABLE W/LONG FEET L320 F/P

    MDR report key: 3171577 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02983
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    October 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION OF THE DISTRACTOR IN QUESTION CONFIRMS THAT THE ADJUSTABLE FOOT NO LONGER CAN HOLD THE ORIGINAL POSITION. THERE IS EVIDENCE THAT THE DEFECT HAS RESULTED FROM NORMAL WEAR AND TEAR. IN ADDITION, THE INVESTIGATION OF THE MATERIAL AND ORIGINAL DOCUMENTS HAS SHOWN THAT THE DISTRACTOR IN QUESTION WAS PRODUCED IN ACCORDANCE WITH THE RELEVANT SPECIFICATIONS AND SINCE THEN HAS BEEN IN REGULAR USE. NO PRODUCT DEFECT COULD BE DETERMINED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED ON AN UNKNOWN DATE THAT ONE SIDE OF THE TIP OF THE DEVICE IS LOOSE. THE LITTLE FEET SHOULD HOLD EACH POSITION. ONE FOOT, HOWEVER, ALWAYS TILTS UNDER. IT IS UNKNOWN WHERE THIS WAS DISCOVERED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272585 DISTRACT ADJUSTABLE W/LONG FEET L320 F/P HTD SYNTHES GMBH T927965

    Patients

    Seq Age Sex Outcome Treatment
    1