BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, SYSTEM UNKNOWN

    MDR report key: 2715518 · Received August 27, 2012

    Report

    Report Number
    1526439-2012-00190
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    June 13, 2012
    Report Date
    August 27, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS-FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    MEDWATCH 3500A FORM RECEIVED FROM (B)(4). EVENT DESCRIPTION: WHEN REMOVING SCREW FROM PATIENT USING THE DEPUY SYSTEM, THE SCREWDRIVER HEAD BROKE OFF INTO THE HEAD OF THE SCREW. THE UNIVERSAL HARDWARE SCREW REMOVAL SYSTEM WAS USED AFTER SEVERAL ATTEMPTS WERE MADE TO REMOVE THE SCREW. THE SITUATION PROLONGED THE SURGERY FOR APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER, SYSTEM UNKNOWN MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR