BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ALIGNMENT HANDLE

    MDR report key: 3841531 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05089
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THAT THE INSTRUMENT SHOWED SIGNS OF EXTENDED USE AND THE DUCTILE FRACTURE MAY HAVE OCCURRED DUE TO SHOCK OR A QUICK OVERLOAD APPLIED TO THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON UNKNOWN DATE. DURING THE PROCEDURE, A RING FRACTURED OFF THE TIBIAL HANDLE OF THE VANGUARD MINI ALIGNMENT HANDLE AND INTO THE PATIENT'S BODY. THE RING WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317924 MINI ALIGNMENT HANDLE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 325980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention