BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN MENSICAL REPAIR DEVICE - CURVED

    MDR report key: 6556904 · Received May 10, 2017

    Report

    Report Number
    0001825034-2017-03161
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 10, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    PK111564
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PRODUCTS WERE VISUALLY EXAMINED. FOR THE MAXFIRE STRAIGHT, ONE OF THE DEVICES HAD A FRACTURED NEEDLE SLED. THE SECOND DEVICE DID NOT EXHIBIT ANY DAMAGE TO THE NEEDLE SLED. FOR THE MAXFIRE CURVED, THE NEEDLE SLED WAS SEVERELY BENT. IT IS UNKNOWN HOW THE DAMAGES TO THE NEEDLE SLEDS OCCURRED BUT THIS MAY HAVE CONTRIBUTED TO THE EVENT OF THE THUMB WHEEL BECOMING STUCK. WHEN DISASSEMBLED, THE COMPLAINT DEVICES HAD THE THUMB WHEEL TEETH FACING UPWARD. THE THUMB WHEELS HAD VISIBLE DAMAGE/WEAR TO THEM. DUE TO THE DAMAGE ON THE NEEDLE SLEDS ON TWO OF THE DEVICES, IT IS THOUGHT THAT THE THUMB WHEEL JAMMING/WEAR WAS A SECONDARY FAILURE TO THE DAMAGE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). CONCOMITANT PRODUCTS: MAXFIRE MARXMEN MENISCAL REPAIR DEVICE - STRAIGHT CATALOG #: 900320 LOT #: 520960. CUSTOMER HAS INDICATED THAT THE DEVICE IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-03169).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE PROCEDURE, THE THUMB WHEEL BECAME STUCK, RESULTING IN THE SURGEON'S INABILITY TO CONTROL THE DEPTH PENETRATION OF THE NEEDLE SLED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340234 MAXFIRE MARXMEN MENSICAL REPAIR DEVICE - CURVED FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE N/A 521490

    Patients

    Seq Age Sex Outcome Treatment
    1