BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT

    MDR report key: 9166186 · Received October 7, 2019

    Report

    Report Number
    MW5090245
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 3, 2019
    Manufacturer
    SPIGGLE & THEIS MEDIZINTECHNIK GMBH / JEDMED
    Product Code
    JYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT (WEAPON MICRO EAR INSTRUMENT) BROKE WHILE SURGEON WAS USING IT DURING PROCEDURE (R TYPE 3 TYMPANOPLASTY WITH CARTILAGE GRAFT). THE END OF THE INSTRUMENT SNAPPED OFF AND BROKE IN TO TWO PIECES. THE PIECE THAT BROKE OFF WAS RETRIEVED FROM THE WOUND. NO HARM EVIDENT, INSTRUMENT WAS RETAINED FOR REVIEW. THE ITEM IS A 16CM LONG ROSEN ROUND KNIFE #10-610-25. THE SMALLEST DIAMETER AT 2MM IS WHAT BROKE OFF IN THE PT. THE OPPOSITE END OF THIS INSTRUMENT (HANDLE) IS 5MM IN DIAMETER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958067 ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT KNIFE, EAR JYO SPIGGLE & THEIS MEDIZINTECHNIK GMBH / JEDMED 10-610-25 045/04-19

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR