BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III AC+ GUN

    MDR report key: 8981146 · Received September 10, 2019

    Report

    Report Number
    1221934-2019-58234
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 14, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    LXH
    UDI-DI
    10886705027101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED TO DETERMINE IF THE DEVICE HAD ANY GROSS VISUAL DEFECTS THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. HOWEVER,IT IS OBSERVED THAT A PIECE OF THE TOP JAW OF THE PASSER WAS SNAPPED OFF.THE END OF THE PASSER WAS BROKEN CONFIRMING THE COMPLAINT CONDITION. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE DUE TO BLUNT FORCE IMPACT/USER MISHANDLING OF THE DEVICE. HOWEVER,THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ALSO, THIS DEVICE IS CLOSE TO 9 YEARS OLD AND HAS SEEN HEAVY USE.THE MANUFACTURING RECORD EVALUATION WAS PERFORMED AND IDENTIFIED A [NCR:16613] RELATED TO THE REPORTED INCIDENT. THE NECESSARY ACTIONS TO ENSURE THE FINAL PRODUCT QUALITY HAVE BEEN TAKEN AND DOCUMENTED IN THE APPROPRIATE QUALITY SYSTEM. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. 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. DEVICE HISTORY: 1 REJECTION FOUND. PN: 288233. LOT: 46780. DESC: EXPRESSEW III AC + GUN. REJ TYPE: FUNCTIONAL. NCR: 16613. REJ DESC: COMPONENT 112184 BROKEN TIP. DISPOSITION: REWORKED/REPLACED COMPONENTS ON 1/10 DEVICES" 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 Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS COMPANY REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE EXPRESSEW III AUTOCAPTURE + SUTURE PASSER WAS BEEN USED FOR A ROTATOR CUFF REPAIR. IT WAS NOTICED DURING SURGERY THAT THE END OF THE EXPRESSEW WAS BROKEN. THE HOOK ON THE TOP JAW OF THE PASSER WAS SNAPPED OFF. THIS WAS SPOTTED WHEN THE PASSER DID NOT RETRIEVE THE SUTURE, HOWEVER, IT IS NOT KNOWN WHETHER THE END OF THE PASSER BROKE DURING SURGERY OR BEFORE. THE PATIENT WAS X-RAYED TO ENSURE THAT THERE WAS NO METAL PRESENT IN THE SHOULDER, THERE WAS NO TRACE FOUND. A SURGICAL DELAY OF APPROXIMATELY 5 TO 10 MINUTES WAS REPORTED THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775267 EXPRESSEW III AC+ GUN MISC ORTHO SURGICAL INSTR LXH MEDOS INTERNATIONAL SàRL 288233 10886705027101

    Patients

    Seq Age Sex Outcome Treatment
    1