BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5X5MM HT SD X-DR SCR EA

    MDR report key: 20461654 · Received October 16, 2024

    Report

    Report Number
    0001032347-2024-00316
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 10, 2024
    Report Date
    April 18, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053741
    PMA / PMN Number
    K121589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 1.5X5MM HT SD X-DR SCR EA CAT# 91-6105 LOT# J66799367. 1.5X5MM HT SD X-DR SCR EA CAT# 91-6105 LOT# J66799367. G2: COLOMBIA. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SCREWS WERE FRACTURED DURING PLACEMENT OF THE BONE FLAP. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREWS FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ALTERNATIVE DEVICES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321744 1.5X5MM HT SD X-DR SCR EA ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE JEY BIOMET MICROFIXATION NI J66799367 00841036053741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male