BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL BROACH IMPACTOR

    MDR report key: 10023917 · Received May 5, 2020

    Report

    Report Number
    0001822565-2020-01619
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 23, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D10, G4, G7, H1, H2, H3, H6, AND H10. VISUAL EVALUATION OF THE RETURNED INSTRUMENT CONFIRMED TO BE HEAD ROD WAS FRACTURED. SEVERAL DAMAGES (NICKS AND GOUGES) WERE SEEN IN THE HEAD ROD DUE TO REPEATED USE FOR MORE THAN TEN YEARS. MEDICAL RECORDS ARE NOT PROVIDED. THE RECEIVING INSPECTION REPORT WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO REPEATED USE OF THIS INSTRUMENT FOR MORE THAN TEN-YEAR FIELD LIFE; WHICH CAUSES WEAR AND TEAR TO THE INSTRUMENT AND LED TO FRACTURE. PER PACKAGE INSERT (87-6203-066-01, REV K) INSPECT ALL INSTRUMENTS/PROVISIONAL CAREFULLY PRIOR TO EACH USE. IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT USE THE DEVICE AND CONTACT YOUR ZIMMER REPRESENTATIVE FOR A REPLACEMENT. IT IS ALSO NOTED IN THE IFU - ANY DECISION TO REMOVE A BROKEN DRILL OR DRILL FRAGMENTS IS LEFT TO THE SURGEON¿S DISCRETION AND MUST TAKE INTO ACCOUNT THE ASSOCIATED RISKS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP OF A TIBIA BROACH IMPACTOR FRACTURED OFF. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490545 TIBIAL BROACH IMPACTOR IMPACTOR HWA ZIMMER BIOMET, INC. N/A 61502437

    Patients

    Seq Age Sex Outcome Treatment
    1