BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUGMENT REAMER DRIVER

    MDR report key: 11020041 · Received December 16, 2020

    Report

    Report Number
    0001822565-2020-04054
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: (B)(4) VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE ITEM WAS RETURNED BECAUSE THE HEX BALL WAS FRACTURED OFF. ITEM AND LOT NUMBERS ARE CONFIRMED TO MATCH THE COMPLAINT. HARDNESS WAS CHECKED USING GAGE 25-1003-690-07-A AND FOUND TO BE CONFORMING. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORTS WERE FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORTS WERE FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE EVENT WAS INITIALLY REPORTED ON 0001825034-2020-04030.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REAMING FOR THE AUGMENT, THE HEX BALL FRACTURED OFF OF THE SHAFT OF THE REAMER DRIVER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489550 AUGMENT REAMER DRIVER ORTHOPAEDIC BALL SPIKE HWR ZIMMER BIOMET, INC. NI 64832651

    Patients

    Seq Age Sex Outcome Treatment
    1