BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER MODULE FOR TRAUMA RECON SYSTEM

    MDR report key: 8939695 · Received August 28, 2019

    Report

    Report Number
    8030965-2019-67767
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 16, 2019
    Report Date
    August 16, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INCLUDE THE ADDITIONAL DEVICES COMMUNICATED DURING SUBSEQUENT FOLLOW UP WITH THE REPORTER: LID DEVICE, COUPLING DEVICE AND ATTACHMENT DEVICES. THE EVENT HAS BEEN UPDATED TO 2 OF 6 FOR THE SAME EVENT. CONCOMITANT MED PRODUCTS AND THERAPY DATES: HANDPIECE DEVICE, POWER MODULE DEVICE, LID DEVICE, COUPLING DEVICE AND ATTACHMENT DEVICES, (B)(6) 2019. THE DEVICE PRO-CODE WAS INITIALLY REPORTED AS HWE AND HAS BEEN UPDATED TO MOQ. THE DEVICE BRAND NAME AND COMMON DEVICE NAME HAVE BEEN UPDATED ACCORDINGLY. THE DEVICE SERIAL NUMBER, DATE OF MANUFACTURE AND MANUFACTURE SITE NAME AND ADDRESS WERE DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE SERIAL NUMBER, DATE OF MANUFACTURE AND MANUFACTURE SITE NAME AND ADDRESS HAVE ALL BEEN UPDATED ACCORDINGLY. THE UDI HAS ALSO BEEN UPDATED ACCORDINGLY. UDI: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. CORRECTION H6: UPON FURTHER INVESTIGATION OF THE DEVICE EVALUATION, IT WAS DETERMINED THAT THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. HOWEVER, A DEVICE HISTORY REVIEW WAS PERFORMED WHICH INDICATED THAT THERE WERE NO RELEVANT ISSUES IDENTIFIED DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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

    CONCOMITANT MED PRODUCTS AND THERAPY DATES: BATTERY HANDPIECE DEVICE, (B)(6) 2019. THE DEVICE SERIAL/LOT NUMBER AND CATALOG NUMBER IS UNKNOWN THEREFORE UDI WAS UNKNOWN. CATALOG NUMBER, SERIAL NUMBER AND LOT NUMBER ARE UNKNOWN. BRAND NAME WAS UNKNOWN. THE MANUFACTURING LOCATION WAS UNKNOWN. 510(K) NUMBER WAS UNKNOWN. DEVICE MANUFACTURE DATE WAS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED ORTHOPEDIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY HANDPIECE DEVICE WHILE BEING USED WITH AN ATTACHMENT DEVICE BECAME HOT AND WAS EMITTING A LOUD SOUND. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    736859 POWER MODULE FOR TRAUMA RECON SYSTEM BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1