BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER 7MM BEAK WIDTH

    MDR report key: 3003345 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10401
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFO IS UNK, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD¿L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MFG RECORDS WERE REVIEWED AND NO IRREGULARITIES WERE FOUND. THE SUBJECT DEVICE WAS CORRESPONDED TO DRAWINGS AND PROCESSES IN PLACE AT THE TIME OF MFR. IT IS PRESUMED THAT TOO MUCH FORCE WAS APPLIED TO THE TIPS OF THE INSTRUMENT, CAUSING ONE BREAK.

    Description of Event or Problem · 1

    DURING A FOOT AND ANKLE PROCEDURE, THE TEETH/TIP OF THE LAMINA SPREADER BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND CONFIRMED BY X-RAY. THE PROCEDURE WAS COMPLETED, AND THE BROKEN TIP WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87282 BONE SPREADER 7MM BEAK WIDTH LXH SYNTHES GMBH T945382

    Patients

    Seq Age Sex Outcome Treatment
    1