BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO TORNADO HP W HANDCONTROL

    MDR report key: 9622014 · Received January 23, 2020

    Report

    Report Number
    1221934-2020-00277
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 13, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705016938
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ==> THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT THE UNIT TORNADO MICRO HANDPIECE WITH BUTTONS DOES NOT HOLD BURRS. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, THE REPORTED FAILURE WAS CONFIRMED.   DURING EVALUATION, THE KEYPAD WAS NOT RESPONDING PROPERLY AND THE VALUES WERE OUF OF RANGE. ADDITIONALLY, IT WAS NOTED THAT THE DRILL MOUNTING MECHANISM HAD MISSING COMPONENTS. PHYSICAL DAMAGE WAS FOUND IN A HANDPIECE AND THE BLADE WAS DISASSEMBLING. THE REPAIR AND TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL, BRINGING THE UNIT BACK TO FULL FUNCTIONALITY. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE WAS THUS IDENTIFIED AS PHYSICAL DAMAGE AND THE BLADE DISASEMBLES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1151M3530] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED, AS THE DEVICE WAS REPAIRED AND IS FULLY FUNCTIONAL. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1151M3530] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE BLADE LOCKING RING DID NOT HOLD THE BURR; AND THAT THE BURR COULD NOT BE INSERTED. D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT "WLLONOUP" MEDWATCH WILL BE FILED AS APPROPRIATE. FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE VIA PHONE, THAT DURING AN UNKNOWN PROCEDURE, A FMS TORNADO MICRO HANDPIECE WITH BUTTONS DOES NOT HOLD BURRS. THE PROCEDURE WAS COMPLETED BY USING A REPLACEMENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85524 MICRO TORNADO HP W HANDCONTROL LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM HRX DEPUY MITEK LLC US 283512 10886705016938

    Patients

    Seq Age Sex Outcome Treatment
    1