BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI-SCREWANCHOR1BLUE SUTU

    MDR report key: 7486432 · Received May 4, 2018

    Report

    Report Number
    0001825034-2018-03183
    Event Type
    Injury
    Date Received
    May 4, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK012503
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED MEDICAL NOTES WHICH PATIENT UNDERWENT REVISION SURGERY TO REMOVE TWO SUTURE ANCHORS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). FOUR SCREWS WERE INITIALLY IMPLANTED, AND TWO SCREWS WERE REVISED. THE PRODUCT IDENTIFICATIONS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN AFTER FOLLOW-UP ATTEMPTS WHICH DEVICE(S) WERE REVISED AND WHICH WERE IMPLANTED. THE INFORMATION FOR THE ADDITIONAL SCREWS IS AS FOLLOWS: ITEM NAME: 3.0 MM TI-SCREWANCHOR1BLUE SUTU, CATALOG NUMBER: 902554, LOT NUMBER: 148700, EXPIRATION DATE: SEP 30, 2013, MANUFACTURE DATE: SEP 24, 2003. ITEM NAME: 3.0 MM TI-SCREWANCHOR1BLUE SUTU, CATALOG NUMBER: 902554, LOT NUMBER: 148700, EXPIRATION DATE: SEP 30, 2013, MANUFACTURE DATE: SEP 24, 2003. ITEM NAME: 5.0 MM TI-SCREWANCHOR DBL2SSUTU, CATALOG NUMBER: 902556, LOT NUMBER: 171200, EXPIRATION DATE: OCT 31, 2013, MANUFACTURE DATE: OCT 30, 2003. POSSIBLE INITIAL (B)(6) 2003 AND POSSIBLE REVISION (B)(6) 2011. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018- 01794. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND BONE SPURS DUE TO THE SCREW MIGRATION FROM THE BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330014 3.0MM TI-SCREWANCHOR1BLUE SUTU FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 153230

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other