BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 7MM SPAGETTIBOHRER

    MDR report key: 5004068 · Received August 14, 2015

    Report

    Report Number
    0001825034-2015-03640
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 23, 2015
    Report Date
    September 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDX
    PMA / PMN Number
    PK900003
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03640 / 03641).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. IT IS AN OSCILLATING CUTTING TOOL THAT REQUIRES SPECIFIC OPERATION CHARACTERISTICS AND THE PATIENT IS TO BE WARNED THAT TOOL TIPS CAN BREAK OR OTHERWISE FAIL DURING SURGERY, AND THAT FRAGMENTS OF BROKEN TOOL TIPS CAN REMAIN AT THE SURGICAL SITE AFTER SURGERY. THE HAND PIECE WAS NOT RETURNED FOR EVALUATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP ARTHROPLASTY OVER 7 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE DISK DRILL FRACTURED OFF THE ULTRA DRIVE HAND PIECE AND THE HAND PIECE SHOWED A FAILURE MESSAGE. THE SURGEON OPENED THE FEMUR IN HALF TO REMOVE THE FRACTURED DISK DRILL RESULTING IN OVER A 90 MINUTE DELAY IN THE PROCEDURE. CABLE IMPLANTS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539065 ULTRA DRIVE 7MM SPAGETTIBOHRER INSTRUMENT, SURGICAL JDX BIOMET ORTHOPEDICS N/A 868180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R