BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 8244348 · Received January 14, 2019

    Report

    Report Number
    8030965-2019-59828
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    October 16, 2018
    Report Date
    October 22, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    7611819085268
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE MANUFACTURE DATE WAS DOCUMENTED AS 02/05/2009 IN THE INITIAL REPORT AND HAS BEEN UPDATED AS 09/09/02009. THE UDI HAS BEEN UPDATED 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

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF THE SERVICE HISTORY RECORD INDICATES THAT THE DEVICE HAD NOT BEEN RETURNED PREVIOUSLY FOR THE SAME MALFUNCTION. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE MOTOR POWER WAS TOO LOW. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A CONNECTION FAILURE AND WAS BEING USED WITH AN ATTACHMENT DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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
    36876 COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC N/A 7611819085268

    Patients

    Seq Age Sex Outcome Treatment
    1