BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM/1.1MM DOUBLE DRILL SLEEVE

    MDR report key: 3003372 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10409
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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. A REVIEW OF DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. THE MFG VISUAL INSPECTION NOTED ONE TIP OF THE DRILL GUIDE WAS BROKE OFF. THE BROKEN FRAGMENT EXHIBITED THE FOREFRONT BENT INWARD AT ONE SIDE, MAKING THE DIAMETER TOO SMALL. THE DRILL BIT COULD GET CAUGHT IN THE GUIDE AND SHEARING THE SMALL PART OF THE GUIDE OFF. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE REASON WHY THE FOREFRONT OF THE BROKEN FRAGMENT WAS BENT INWARD.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION INTERBODY FUSION (ORIF) OF THE RADIAL HEAD, THE TIP OF THE DRILL BENT AND BROKE OFF. THE BROKEN TIP WAS RETRIEVED. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87292 1.5MM/1.1MM DOUBLE DRILL SLEEVE FZX SYNTHES GMBH 2504718

    Patients

    Seq Age Sex Outcome Treatment
    1