BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III GUN W/HOOK

    MDR report key: 2855085 · Received December 3, 2012

    Report

    Report Number
    1221934-2012-00327
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED: OUTSIDE OF THE FACT THAT A PORTION OF THE JAW PIN IS MISSING AS REPORTED, THE DEVICE APPEARS IN GOOD CONDITION. FURTHER, THE DEVICE FUNCTIONS; IT CAN BE MANIPULATED, ACCEPTS NEEDLES AND IS ABLE TO DEPLOY SAID NEEDLES. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT; OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. IT DOES APPEAR THAT THE FAILURE MODE MAY BE A MANUFACTURING DEFECT, AND, OUTSIDE OF THAT CONSIDERATION, NO OTHER ROOT OR UNDERLYING CAUSE CAN BE DISCERNED; WE ATTRIBUTE THE DEVICE'S CONDITION TO AN ANOMALY. THE DEVICE IS BEING FORWARDED TO THE MANUFACTURE FOR AN IN DEPTH ROOT CAUSE EVALUATION, IF THE RESULTS OF THEIR INVESTIGATION REVEALS ANY ROOT CAUSE, THIS FILE WILL BE MADE TO REFLECT THOSE CONCLUSIONS AND A FOLLOW-UP REPORT WILL BE SUBMITTED. OUTSIDE OF THIS, NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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.

    Description of Event or Problem · 1

    OUR REP. IS REPORTING TO US THAT DURING AN OPEN SHOULDER REPAIR, A JAW PIN FROM THEIR SUTURE PASSER GUN FELL AWAY INTO THE BODY. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK EXPRESSEW III GUN W/HOOK ARTHROSCOPIC INSTRUMENTS LXH DEPUY MITEK NA 9640

    Patients

    Seq Age Sex Outcome Treatment
    1