BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT DRIVER RMAS

    MDR report key: 2822866 · Received November 7, 2012

    Report

    Report Number
    1030489-2012-02008
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    November 2, 2012
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BREAKAGE OF THE HEX 3.5 MM TIP IS CONSISTENT WITH OVERLOADING IN TORSION TO THE DRIVER DURING THE TIGHTENING OF THE SCREW. NON-CONFORMANCE TO SPECIFICATION HAS BEEN RECORDED FOR THE LOT NUMBER CT10A076 WITHOUT ANY IMPACT TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT DRIVER RMAS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC CT10A076

    Patients

    Seq Age Sex Outcome Treatment
    1