BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI W/ MAXBRAID NDLS

    MDR report key: 13497563 · Received February 9, 2022

    Report

    Report Number
    0001825034-2022-00285
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    January 27, 2022
    Report Date
    April 15, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00880304009677
    PMA / PMN Number
    K080088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS" CAT: 902571 LOT: 070670 5.0MM TI W/ MAXBRAID NDLS, CAT: 902581 LOT: 362840 5.0 ALLTHREAD TI 2#2 MB TPRD N, CAT: 902582 LOT: 451440 6.5 ALLTHREAD TI 2#2 MB TPRD N. REPORT SOURCE: FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING THE FOLLOWING SECTION WAS CORRECTED: B4 (EXPIRATION DATE), B4 (UDI#). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TISCREW ANCHORS BROKE AND WERE RETAINED IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086196 5.0MM TI W/ MAXBRAID NDLS SCREW, FIXATION HWC ZIMMER BIOMET, INC. 902571 173540 00880304009677

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O SEE NARRATIVE IN H10