BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5X6MM HT SD X-DR SCR EA

    MDR report key: 12445703 · Received September 9, 2021

    Report

    Report Number
    0001032347-2021-00420
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 2, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THAT THREE SCREW HEADS FRACTURED AND ANOTHER SCREW STRIPPED. THERE WAS A THIRTY MINUTE DELAY DURING THE SURGERY.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021 - 00421, 0001032347 - 2021 - 00427, 0001032347 - 2021 - 00428. MEDICAL PRODUCTS ITEM #91-6107, LOT #991620. ITEM #91-6106, LOT #J398520 QTY 2. REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THAT THREE SCREW HEADS FRACTURED AND ANOTHER SCREW STRIPPED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348737 1.5X6MM HT SD X-DR SCR EA PLATE, BONE JEY BIOMET MICROFIXATION N/A J398520

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female SEE H10.