BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0X 5MM DIR-DRV LACT SCW 2PK

    MDR report key: 11787162 · Received May 6, 2021

    Report

    Report Number
    0001032347-2021-00252
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 3, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036054687
    PMA / PMN Number
    K011139
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INCORRECT QUANTITY WAS REPORTED AND THIS MALFUNCTION DOES NOT HAVE A TRUE SENTINEL EVENT FOR THIS PRODUCT LINE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00251, 0001032347-2021-00253, 0001032347-2021-00254. DEVICE AVAILABLE FOR EVALUATION: ITEM# 915-2200; LOT# 893220, ITEM# 915-2201; LOT# 893660, ITEM# 915-2201; LOT# 893660. REPORT SOURCE - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY THREE (3) WEEKS AGO THAT A PATIENT UNDERWENT AN INITIAL SEGMENT PROCEDURE. DURING IMPLANTATION, THE SCREWHEAD DID NOT FIT TIGHT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682618 2.0X 5MM DIR-DRV LACT SCW 2PK PROSTHESIS, MICROFIXATION HWC BIOMET MICROFIXATION NI 893220 00841036054687

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE NARRATIVE IN H10