BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW

    MDR report key: 8896978 · Received August 15, 2019

    Report

    Report Number
    0001032347-2019-00388
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MBI
    UDI-DI
    00841036055332
    PMA / PMN Number
    K013557
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT CANNOT BE VERIFIED. THE COMPLAINT WAS OPENED BECAUSE LAUREN CUCCI, CSR, REPORTS ON BEHALF OF THE FACILITY THAT A SCREW BROKE DURING A PROCEDURE. THE 2.0X5MM SUS PUSH SCR 2/PK (PART#: 915-2336, LOT#: UNK) WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, THE PRODUCT COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED. THE DHR FOR THIS PRODUCT COULD NOT BE REVIEWED DUE TO THE LOT NUMBER BEING UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (915-2336) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE), THERE IS A COMPLAINT RATE OF 0.127%, WHICH IS ALREADY BELOW THE OCCURRENCE RATE OF THIS FAILURE MODE. THE MOST LIKELY UNDERLYING CAUSE COULD NOT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW BROKE DURING A PROCEDURE. THERE WAS A DELAY OF A FEW MINUTES WHILE A REPLACEMENT SCREW WAS PROCURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691740 LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET MICROFIXATION N/A UNK 00841036055332

    Patients

    Seq Age Sex Outcome Treatment
    1