BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 9562288 · Received January 8, 2020

    Report

    Report Number
    1030489-2020-00038
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 13, 2019
    Report Date
    April 3, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULTS: VISUAL INSPECTION REVEALED THE HEX TIP OF THE DRIVER HAS BEEN BROKEN OFF. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALS A QUA SI-BRITTLE FRACTURE SURFACE WITH RIVER LINES AND NO INDICATION OF FATIGUE OR TORSION. THERE IS SOME DAMAGE TO THE FIRST ROW OF THREADS ON THE DRIVER. THE THREADED PORTION OF THE DRIVER SLEEVE IS DESIGNED TO MITIGATE INSTRUMENT MISALIGNMENT AND ASSOCIATED BENDING STRESSES. THIS IS CONSISTENT WITH NOT FULLY ENGAGING THE THREADED PORTION OF THE DRIVER SLEEVE INTO THE MAS HEAD. THE ANGULATION AND MORPHOLOGY OF THE FRACTURE SURFACE, IN ADDITION TO THE MAS HEAD THREAD DAMAGE SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION (REVISION SURGERY) DUE TO NON UNION. INTRA-OP, TIP OF DRIVER BROKE OFF WHILE EXPLANTING A SCREW. THERE WERE NO FRAGMENTS OF THE INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25458 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA PR10E003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR