BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III AC+ GUN

    MDR report key: 8901068 · Received August 16, 2019

    Report

    Report Number
    1221934-2019-58021
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 18, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    LXH
    UDI-DI
    10886705027101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: 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 PART OF THE TIP OF THE TOP JAW WAS BROKEN. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. WE CANNOT DISCERN A ROOT CAUSE, HOWEVER, THE INFORMATION PROVIDED STATES THAT THE REPORTED ISSUE OCCURRED ON THE BACK TABLE OF THE OPERATING ROOM, A POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO EXCESSIVE FORCE DURING THE TECHNIQUE.HOWEVER,THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 51168-190218 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. UDI (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT POST TO A ROTATOR CUFF REPAIR PROCEDURE ON THE BACK TABLE WHEN REMOVING THE RETENTION PLATE FROM THEIR EXPRESSEW III AUTO CAPTURE + GUN, THE DISTAL END OF THE TOP JAW, THE PART BETWEEN WHERE THE RETENTION PLATE MEETS WHERE THE NEEDLE COMES THROUGH (THE UPSIDE L PART OF THE JAW) BROKE OFF. THE SALES REP STATED THAT NOTHING BROKE IN THE PATIENT AS THE ISSUE OCCURED ON THE BACK TABLE OF THE OPERATING ROOM. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE BEFORE THE ISSUE OCCURRED. THERE WAS NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694504 EXPRESSEW III AC+ GUN SUTURE/NEEDLE PASSER, REUSABLE LXH MEDOS INTERNATIONAL SàRL 10886705027101

    Patients

    Seq Age Sex Outcome Treatment
    1