BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD PS BOX REAMER 62.5-67.5MM

    MDR report key: 4814981 · Received June 3, 2015

    Report

    Report Number
    0001825034-2015-02406
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    April 24, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD
    Product Code
    JWH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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, IT 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. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE REAMER TIP FRACTURED. THE INSTRUMENT DID NOT FRACTURE IN THE PATIENT AND THERE WAS NO REPORTED DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358099 VANGUARD PS BOX REAMER 62.5-67.5MM REAMER JWH ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD N/A ZB140603

    Patients

    Seq Age Sex Outcome Treatment
    1