BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1973068 · Received January 28, 2011

    Report

    Report Number
    1030489-2011-00082
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED DRILL BIT IS BROKEN. APPROXIMATELY 8MM HAS BEEN BROKEN OFF OF THE TIP AND NOT RETURNED FOR ANALYSIS. FRACTURE APPEARANCE IS FAIRLY BRITTLE WITH SECONDARY CRACKING, INDICATIVE OF OVERLOAD. INSTRUMENT IS MARKETED AND SOLD AS A SINGLE-USE INSTRUMENT. THE INVESTIGATION SUGGESTS MULTIPLE USE OF THE INSTRUMENT AS A POTENTIAL CONTRIBUTOR TO FAILURE. THE AGE OF THE INSTRUMENT SUGGESTS THIS AS A POSSIBLE CONTRIBUTOR TO FAILURE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE DUE TO INAPPROPRIATE SURGICAL TECHNIQUE, RESULTING IN THE FOREGOING EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE DURING A DRILLING PROCESS AT A CERVICAL PROCEDURE. INTRA-OPERATIVE AND POST-OP X-RAYS DID NOT REVEAL ANY TRACE OF THE BROKEN TIP LEFT INSIDE OF THE PATIENT BODY. HOWEVER, THE BROKEN OFF TIP WAS NOT FOUND IN THE OPERATIVE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA NG07G001

    Patients

    Seq Age Sex Outcome Treatment
    1