BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO TORNADO HP W HANDCONTROL

    MDR report key: 8654319 · Received May 30, 2019

    Report

    Report Number
    1221934-2019-57234
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    May 8, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705016938
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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. UDI: (B)(4). MANUFACTURER SITE: THE MANUFACTURER NAME WAS UPDATED TO MEDOS INTERNATIONAL SàRL. MANUFACTURING SITE NAME AND ADDRESS HAVE BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND WAS EVALUATED. THE REPORTED COMPLAINT THAT THE HANDPIECE WAS BROKEN IN 2+ PIECES WAS NOT CONFIRMED. HOWEVER, ON INSPECTING THE DEVICE, FURTHER DEFICIENCIES WERE FOUND TO BE IMPAIRING DEVICE FUNCTION. IT WAS FOUND THAT THERE WAS A SHORT CIRCUIT IN THE MOTOR CABLE. THE MOTOR CABLE WAS REPLACED. THE COMPLAINT DEVICE WAS CLEANED, REPAIRED AND TESTED FOR FUNCTIONALITY. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE SHORT CIRCUIT. SINCE THE REPORTED CONDITION IS NOT CONFIRMED,THE ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED. THE SERVICE HISTORY HAS BEEN REVIEWED IN LIEU OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SINCE IT WAS PREVIOUSLY SERVICED. THE DEVICE WAS LAST SERVICED ON (B)(6) 2018 AND PASSED ALL FUNCTIONAL TESTING BEFORE BEING RETURNED TO THE CUSTOMER. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(4) VIA PHONE THAT DURING PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MICRO TORNADO HANDPIECE WITH HAND CONTROLS WAS BROKEN. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED ON 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448095 MICRO TORNADO HP W HANDCONTROL LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM HRX MEDOS INTERNATIONAL SàRL 10886705016938

    Patients

    Seq Age Sex Outcome Treatment
    1