BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL TORNADO BURR 5.5MM 5PK

    MDR report key: 12635144 · Received October 14, 2021

    Report

    Report Number
    1221934-2021-02992
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Report Date
    October 1, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705022106
    PMA / PMN Number
    K131191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICES DON'T CLICK ON THE HANDPIECE DEVICES REPORTED IN THIS COMPLAINT WERE NOT RECEIVED FOR EVALUATION, HOWEVER; OTHER DEVICES REPORTED UNDER OTHER CUSTOMER COMPLAINTS FOR THE ISSUE ¿CUTTER CANNOT SNAP ONTO THE MICRO TORNADO SHAVER¿ WERE RECEIVED AND ANALYZED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: M2105041, AND NO NON CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION WAS DIVIDED INTO TWO STAGES, 1ST STAGE CONSISTED IN COMPLAINT BURR VISUAL INSPECTION AND FUNCTIONAL TEST AT THE PRODUCT ANALYSIS LAB, THE RESULT FOR THIS TEST INDICATED THAT THE DEVICES COULD NOT BE ASSEMBLED INTO MICRO TORNADO HANDPIECE (P/N 283512). DUE TO THESE RESULTS, THE BURRS WERE THEN MEASURED, AND IT WAS IDENTIFIED THAT 2 BURR FEATURES OF THE OUTER BLADE HUB WERE OVER THE UPPER LIMIT. DEVICES WERE SENT TO R&D LAB TO CONTINUE WITH THE INVESTIGATION. THE PART UNDERWENT DIMENSIONAL INSPECTION, WHERE IT WAS CONFIRMED THAT 2 BURR FEATURES WERE OVERSIZED (12.575MM FEATURE AND 15.72MM FEATURE). MANUFACTURING WAS NOTIFIED ABOUT THE CONDITION AND A NONCONFORMANCE RECORD NR-0171020 WAS CREATED TO CONTINUE THE INVESTIGATION, ROOT CAUSE DETERMINATION AND MITIGATION OF THE ISSUE. DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: M2105041, AND NO NON CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE WOULD NOT CLICK ON THE HANDPIECE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531387 BARREL TORNADO BURR 5.5MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE HRX DEPUY MITEK LLC US 283889 M2105041 10886705022106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown