BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM DISP DOWEL HARVEST TUBE

    MDR report key: 6125598 · Received November 23, 2016

    Report

    Report Number
    0001825034-2016-04873
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 28, 2016
    Report Date
    July 24, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    Z-2059-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PRODUCT WAS VISUALLY EXAMINED. THERE IS A DEFORMATION ON ONE END OF THE TUBE. THIS LIKELY OCCURRED DURING ATTEMPTS TO ASSEMBLE THE PROTECTION SLEEVE ON THE END. DIMENSIONAL REVIEW WAS COMPLETED TO DETERMINE CONFORMITY OF THE TUBE AND SLEEVE. THE DEVICE DIAMETER WAS MEASURED, AND ACTUAL MEASURED DIMENSION WAS OUT OF TOLERANCE. THEREFORE, IT WAS DETERMINED THAT THE TUBE WAS NONCONFORMING TO PRINT SPECIFICATION. THE PROTECTION SLEVE DIMENSION WAS MEASURED AND DETERMINED TO BE CONFORMING TO PRINT SPECIFICATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE DETERMINED TO BE OPERATOR ERROR (INCORRECT MATERIAL ISSUED). A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8MM BONE HARVEST TUBE COULD NOT BE INSERTED INTO THE 8MM BONE DOWEL COLLET DURING A PROCEDURE. SURGERY WAS COMPLETED WITH 9MM INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776317 8MM DISP DOWEL HARVEST TUBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET SPORTS MEDICINE N/A 889990

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR