BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL INSERTER/EXTRACTOR

    MDR report key: 4782168 · Received May 19, 2015

    Report

    Report Number
    0001825034-2015-02090
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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." 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

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE FAILED DUE TO MISUSE, BY PRODUCT BEING PUT THROUGH TORSIONAL/BENDING OVERLOAD, AND/OR NOT INSPECTED FOR WEAR AND DISFIGUREMENT PRIOR TO USE, WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE STEM INSERTER TIP FRACTURED DURING THE IMPLANTATION OF THE STEM AND REMAINED LODGED IN THE STEM. AS A RESULT, THE STEM HAD TO BE REMOVED AND REPLACED WITH A NEW STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325000 UNIVERSAL INSERTER/EXTRACTOR EXTRACTOR HWB ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD N/A ZB140101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention