BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/HOOK

    MDR report key: 9597943 · Received January 16, 2020

    Report

    Report Number
    1221934-2020-00231
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705003655
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: H6: METHOD CODES: DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (54331-110318), AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS FOR DEVICE RETURN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (54331-110318), 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (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 CUSTOMER'S EXPRESSEW III SUTURE PASSER WITH HOOK KEPT JAMMING WHEN FIRING THE NEEDLE. THE NEEDLE WAS REMOVED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUN USING THE SAME NEEDLE WITH NO PATIENT HARM BUT THERE WAS A TWO MINUTE SURGICAL DELAY TO THE CASE TO GRAB A NEW GUN. THE DEVICE WILL BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59097 EXPRESSEW III W/HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214124 10886705003655

    Patients

    Seq Age Sex Outcome Treatment
    1