BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 10MM

    MDR report key: 10472588 · Received August 31, 2020

    Report

    Report Number
    0001032347-2020-00402
    Event Type
    Injury
    Date Received
    August 31, 2020
    Report Date
    March 2, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036053642
    PMA / PMN Number
    K001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00400-1; 0001032347-2020-00401-1; 0001032347-2020-00403-1. H3: PRODUCT REMAINS IMPLANTED IN PATIENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR ITEMS 91-2710. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE 24-6551 AND 24-6563 DEVICES CAUSED ANY PATIENT INFECTION. THE USER IS REQUIRED TO STERILIZE THE SCREWS PRIOR TO THE PROCEDURE. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00400, 0001032347-2020-00401, 0001032347-2020-00403. MEDICAL PRODUCTS: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6551, LOT# 891840D. TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563, LOT# 886880B. 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 10MM, PART# 91-2710, LOT# NI. TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM, PART# 99-6577, LOT# NI. OCCUPATION: PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT PATIENT THAT THEY EXPERIENCED AN INFECTION THAT WAS TREATED WITH BACTRIM. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934475 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 10MM SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A UNKNOWN 00841036053642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE