BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3231613 · Received July 17, 2013

    Report

    Report Number
    1030489-2013-03055
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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: INSTRUMENT TORQUE MECHANISM FUNCTIONALLY EVALUATED; 36 INDIVIDUAL TORQUE READINGS WERE TAKEN AND THE AVG TORQUE READING WAS DETERMINED TO BE ~ 85 IN/LBS., WHICH IS WITHIN PRINT SPECIFICATION. ALL THIRTY-SIX (36) INDIVIDUAL TORQUE READINGS WERE WITHIN PRINT SPECIFICATION, WITH THE INDIVIDUAL READINGS RANGING FROM 82.9 TO 87.60 IN-LBS (TORQUE SPECIFICATION 80 +/- 8IN/LBS). VISUALLY CONFIRMED DRIVER SHAFT BROKEN; CRACK APPEARS TO HAVE INITIATED NEAR STRESS RELIEF FILLET. MICROSCOPIC EXAMINATION OF FRACTURE REVEALED QUASI-BRITTLE FRACTURE WITH FRACTURE SURFACE CHEVRONS PROVIDING SOME EVIDENCE OF OVERLOAD AS THE MECHANISM OF ULTIMATE FAILURE. THE PERIMETER FRACTURE SURFACE MORPHOLOGY AND THE AGE OF THE PRODUCT ARE CONSISTENT WITH ANTICIPATED WEAR. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR OF THE INSTRUMENT.

    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 PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE DRIVER FRACTURED DURING TIGHTENING OF THE CROSSLINK. THE TIP FRAGMENT FELL INTO THE SURGICAL SITE. THE TIP WAS RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331644 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG NA GB07L001

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR