BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 120M TIP EXTENDER

    MDR report key: 3023828 · Received March 27, 2013

    Report

    Report Number
    0001825034-2013-00757
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND EVIDENCE OF MULTIPLE USES FOR A SINGLE USE INSTRUMENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 5 STATES, THE PATIENT IS TO BE MADE AWARE AND WARNED OF GENERAL SURGICAL RISKS. THE PATIENT IS TO BE WARNED THAT ULTRA-DRIVE TOOL TIPS CAN BREAK OR OTHERWISE FAIL DURING SURGERY, AND THAT FRAGMENTS OF BROKEN TOOL TIPS CAN REMAIN AT THE SURGICAL SITE AFTER SURGERY." NUMBER 6 STATES, "DEVICE IS SINGLE USE ONLY. DO NOT ATTEMPT TO CLEAN OR RE-STERILIZE THIS PRODUCT. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD."

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABILITY - 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. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION OF COMPETITOR PRODUCT DUE TO INFECTION ON (B)(6) 2013. DURING THE PROCEDURE, THE HELICAL BLADE FRACTURED INSIDE THE TIP EXTENDER. AS A RESULT, THE TIP REMAINS INSIDE THE PATIENT'S FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125543 ULTRA DRIVE 120M TIP EXTENDER INSTRUMENT, SURGICAL HTW BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R