BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 8586299 · Received May 7, 2019

    Report

    Report Number
    8030965-2019-63530
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 19, 2019
    Report Date
    April 19, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    07611819085268
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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. ADDITIONAL NARRATIVE: THE MANUFACTURING SITE NAME WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THIS HAS BEEN UPDATED TO SYNTHES PRODUKTIONS GMBH (WALDENBURG). PLEASE NOTE THAT THE CONTACT OFFICE NAME/ADDRESS HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. PLEASE NOTE THAT THE SERIAL NUMBER WAS DOCUMENTED AS UNKNOWN IN THE INITIAL MEDWATCH REPORT. THE SERIAL NUMBER (B)(6) HAS BEEN DOCUMENTED IN SECTION D4 OF THIS MEDWATCH REPORT. IT WAS DOCUMENTED IN THE INITIAL MEDWATCH REPORT THAT THE DATE OF MANUFACTURE (DOM) WAS UNKNOWN. THE DOM ((B)(6) 2013) HAS BEEN UPDATED TO REFLECT THE DATE THE DEVICE WAS MANUFACTURED. THE UNIQUE IDENTIFIER (UDI) HAS BEEN UPDATED ACCORDINGLY. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE DETECTED RELATED TO THE REPORTED CONDITION. ONCE THE EVALUATION OF THE DEVICE HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. UDI:(B)(4).

    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 ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE MOTOR OF THE COMPACT AIR DRIVE DEVICE WAS DAMAGED, THE BLADES OF THE MOTOR WERE BROKEN, AND THIS CONDITION HAS BLOCKED THE MOTOR MOVEMENT. IT WAS FURTHER DETERMINED THAT THE BEARINGS AND GEARS WERE FOUND TO BE WORN OUT AND ODES NOT HAVE FREE MOVEMENT. ADDITIONALLY, IT WAS DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE ATTACHMENT COUPLING CHECK ATTACHMENT COUPLING WITH ATTACHMENTS, CHECK FOR AIR LEAK, AND CHECK TRIGGERS FOR FORWARD / REVERSE MODE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    UDI: LOT/SERIAL UNKNOWN. (B)(4). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. THE MANUFACTURING LOCATION 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 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 FROM PERU THAT DURING A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) SURGICAL PROCEDURE FOR INTERLOCKING, THE ENGINE OF THE COMPACT AIR DRIVE DEVICE STOPPED WORKING DURING THE LAST PERFORATION FOR DISTAL LOCKING. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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
    380380 COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC 07611819085268

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR