BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHCUT REAMER KIT 4.5X9.0MM

    MDR report key: 10777403 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-01520
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    February 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081019001387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXTREMELY BADLY DAMAGED WITH FRICTION MARKS AND TORN PARTS. ALSO , USAGE EXCEEDED EXPECTED PRODUCT LIFE. IT SHOULD BE USED ONLY 1 YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE THE SWITCHCUT REAMER BECAME WEDGED IN THE 4.5MM CANNULA/DRILL SLEEVE. WE THEN OPENED A SECOND SWITCHCUT AND INSTRUMENT SET. AS SURGEON WAS DRILLING THE SWITCHCUT REAMER AGAIN GOT STUCK IN THE SLEEVE AND HE COULDN'T PROCEED. SURGEON HAD TO SWITCH TO ARTHREX TO COMPLETE THE PROCEDURE. 1 HOUR AND 30 MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241070 SWITCHCUT REAMER KIT 4.5X9.0MM SWITCHCUT REAMER KIT 4.5X9.0MM MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 110027680 16R18 01081019001387

    Patients

    Seq Age Sex Outcome Treatment
    1