BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3223700 · Received July 12, 2013

    Report

    Report Number
    1030489-2013-03011
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUALLY CONFIRMED DRIVER SHAFT BROKEN AT TAB FILLETS. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACES PROVIDE SOME EVIDENCE OF FATIGUE AT THE AREA OF FRACTURE PROPAGATION ORIGINATION, SUBSEQUENTLY FOLLOWED BY BRITTLE OVERLOAD, WITH IDENTIFIABLE CHEVRONS THAT ARE AN INDICATION OF OVERLOAD. FRACTURE SURFACE MORPHOLOGY AND CRACK PROPAGATION DIRECTION SUGGEST THE FRACTURE ORIGIN NEAR THE BASE OF THE RETENTION FINGERS AND PROPAGATED AROUND THE DIAMETER OF THE DRIVER. SHAFT DIAMETER AND SHAFT MATERIAL HARDNESS EXAMINED AND FOUND TO BE WITHIN PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL AND PHYSICAL EXAMINATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE INSTRUMENT; UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER BROKE DURING TIGHTENING OF THE SET SCREW. THE SET SCREW ALSO BROKE SO THE SURGEON REMOVED THE SETSCREW WITH PLIERS AND REPLACED IT WITH A NEW SET SCREW. NO PATIENT COMPLICATIONS WERE REPORTED, THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322964 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA DC09J116L

    Patients

    Seq Age Sex Outcome Treatment
    1