BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/HOOK

    MDR report key: 8794373 · Received July 16, 2019

    Report

    Report Number
    1221934-2019-57676
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 17, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705003655
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION REVEALS THAT BOTH THE LOWER AND UPPER JAWS OF THE DEVICE ARE BROKEN OFF. THE SHEAR PIN WAS MISSING, NOT RETURNED. THE TWO TRIGGER MECHANISMS WERE TESTED AND FUNCTIONED AS EXPECTED. THE ROOT CAUSE OF THIS FAILURE IS DEVICE MISUSE. AN EXCESSIVE FORCE WAS PLACED ON THE DISTAL END OF THE DEVICE CAUSING THE SHEAR PIN TO BREAK AND THE JAWS FELL OFF. THIS COMPLAINT CANNOT BE CONFIRMED FOR THE REPORTED FAILURE OF BENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 27339-140709 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 DURING A ROTATOR CUFF REPAIR PROCEDURE THE JAWS OF THE CUSTOMER'S EXPRESSEW III SUTURER PASSER WITH HOOK ARE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH 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
    588815 EXPRESSEW III W/HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 10886705003655

    Patients

    Seq Age Sex Outcome Treatment
    1