BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT EXACT BROACH HANDLE

    MDR report key: 4868529 · Received June 25, 2015

    Report

    Report Number
    0001825034-2015-02734
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 22, 2015
    Manufacturer
    ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. 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 THAT THE ROOT CAUSE OF THE EVENT WAS DUE TO INSTRUMENT BEING OR WORN BEYOND USEFUL LIFE.

    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." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. INITIAL REPORTER ADDRESS - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE BROACH FRACTURED. ANOTHER BROACH WAS UTILIZED TO COMPLETE THE PROCEDURE. A 45 MINUTE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412758 STRAIGHT EXACT BROACH HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MDM ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD N/A ZB090317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention