BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE

    MDR report key: 13509728 · Received February 10, 2022

    Report

    Report Number
    0001032347-2022-00050
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Report Date
    February 10, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00888233007573
    PMA / PMN Number
    K953385
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM SP-ST5-6704, LOT # 221500, STERILE TRAC SYSTEM STERILE TRAC 5 XD THINFLAP 1.5 X 4.0MM SCREW. REPORT SOURCE: FOREIGN: (B)(6). A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PRODUCT PER INSPECTION CRITERIA. THE PACKAGING WAS THEN OPENED TO FURTHER INVESTIGATE THE TOTAL PIECES OF DEBRIS AND A SINGLE HAIR COULD BE SEEN INSIDE THE STERILE PACK. THE COMPLAINT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE IS ATTRIBUTED TO A MANUFACTURING ISSUE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2022-00051.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NON-CONFORMING GOODS WERE DISCOVERED IN THE DISTRIBUTOR'S WAREHOUSE IN (B)(6) 2021. SUBSEQUENTLY, THE ISSUE HAS BEEN IDENTIFIED AS FOREIGN MATERIAL IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844359 STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE PLATE, BONE JEY BIOMET MICROFIXATION N/A 068020 00888233007573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown