BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1932277 · Received December 17, 2010

    Report

    Report Number
    1030489-2010-01605
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL EXAMINATION DID NOT IDENTIFY ANY MATERIAL OR FUNCTIONAL ISSUE WITH THE INSTRUMENT TIP. NO CRACKING, BREAKAGE, MISSING COMPONENTS, OR MISALIGNMENT OF THE JAWS IDENTIFIED. FUNCTIONAL EVALUATION REVEALED NO ISSUES WITH THE INSTRUMENT.

    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 PIVOTING PIN IS BROKEN OFF FROM THE INSTRUMENT. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENTCOMPLICATIONS WERE REPORTED.

    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 GZ07D129

    Patients

    Seq Age Sex Outcome Treatment
    1