BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 9.5MM DISK DRILL

    MDR report key: 4153286 · Received October 8, 2014

    Report

    Report Number
    0001825034-2014-08052
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDX
    PMA / PMN Number
    PK900003
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿INTRAOPERATIVE FRACTURE OR BREAKAGE OF INSTRUMENTS HAS BEEN REPORTED.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE UTILIZING BIOMET'S CEMENT REMOVAL SYSTEM (ULTRA-DRIVE DISK DRILL) TO REMOVE COMPETITOR PRODUCT ON (B)(6) 2014. DURING THE REVISION PROCEDURE, THE DISK DRILL TIP FRACTURED OFF INTO THE CANAL. THE SURGEON WAS UNABLE TO RETRIEVE THE FRACTURED TIP AND IT WAS RETAINED BY THE PATIENT. ANOTHER ULTRA-DRIVE TIP WAS USED TO COMPLETE THE PROCEDURE AND A BIOMET HIP WAS IMPLANTED. A DELAY OF THIRTY MINUTES OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630407 ULTRA DRIVE 9.5MM DISK DRILL INSTRUMENT, SURGICAL JDX BIOMET ORTHOPEDICS N/A 716380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S