BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 7MM DISK DRILL

    MDR report key: 4319225 · Received December 10, 2014

    Report

    Report Number
    0001825034-2014-09055
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    November 17, 2014
    Report Date
    February 2, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY RELATED TO THE EVENT. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE INSTRUMENT FAILURE WAS LIKELY DUE TO CONDITIONS OF USE. AS REPORTED, THE SURGEON STATED THAT THE INSTRUMENT WAS NOT USED AS INTENDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿DO NOT FORCE TOOL TIPS. TOOLS ARE TO BE GUIDED, NOT FORCED. IF THE INSTRUMENT MEETS RESISTANCE, DO NOT FORCE THE TOOL, THE TOOL MAY HAVE CONTACTED CORTICAL BONE. THE APPLICATION OF FORCE CAN CAUSE DAMAGE TO THE CUTTING TIP, THE SYSTEM AND UNNECESSARY DAMAGE TO BONE.¿

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP REVISION PROCEDURE ON (B)(6) 2014 OF COMPETITOR PRODUCT. DURING THE PROCEDURE, THE TIP OF THE ULTRA DRIVE FRACTURED. THE FRACTURED TIP WAS REMOVED FROM THE PATIENT. REGULAR INSTRUMENTATION WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP REVISION PROCEDURE ON (B)(6) 2014 OF COMPETITOR PRODUCT. DURING THE PROCEDURE, THE TIP OF THE ULTRA DRIVE FRACTURED. THE FRACTURED TIP WAS REMOVED FROM THE PATIENT. REGULAR INSTRUMENTATION WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801841 ULTRA DRIVE 7MM DISK DRILL ULTRASONIC SURGICAL INSTRUMENT JXE BIOMET ORTHOPEDICS N/A 333830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention