BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM POLYAXIAL SCREWDRIVER

    MDR report key: 2792721 · Received October 16, 2012

    Report

    Report Number
    1526439-2012-00217
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED POLYAXIAL SCREWDRIVER FOUND BREAKAGE OCCURRED AT THE BASE OF THE FLUTES ON THE DISTAL TIP OF THE INSTRUMENT. EXAMINATION OF THE REMAINING FLUTES UNDER MAGNIFICATION DETERMINED THAT BREAKAGE OCCURRED IN TORSION. THE BROKEN TIP REMAINS IN THE HEX OF THE RETURNED POLYAXIAL SCREW. NO DISCREPANCIES WERE FOUND DURING THE LOT HISTORY REVIEW. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT NUMBER. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATE ACTION ON ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS-FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. ALTHOUGH THE CAUSE OF TIP BREAKAGE CANNOT BE POSITIVELY DETERMINED, THE DAMAGE IS INDICATIVE OF ABNORMAL TORSIONAL SHEAR STRESS PLACED UPON THE INSTRUMENT DURING REMOVAL OF THE SCREW.

    Description of Event or Problem · 1

    CONTACT REPORTED DURING A SURGICAL PROCEDURE, THE SURGEON WAS INSERTING A POLYAXIAL SCREW WHEN HE DECIDED THE NEED TO TAP THE PEDICLE. UPON REMOVAL OF THE SCREW, THE TIP OF THE DRIVER BROKE OFF IN THE SCREWHEAD. THE SURGEON SUCCESSFULLY REMOVED THE SCREW. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM POLYAXIAL SCREWDRIVER MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM MI19392

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), POLYAXIAL SCREW