BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW II FLEXIBLE SUTURE PASSER

    MDR report key: 3241213 · Received July 22, 2013

    Report

    Report Number
    1221934-2013-00188
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    80 DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES FOR FURTHER DETAIL AND COMPLAINT DEVICE RETURN, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT 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.

    Additional Manufacturer Narrative · 1

    80 DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES FOR FURTHER DETAIL AND COMPLAINT DEVICE RETURN, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT 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.

    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.

    Description of Event or Problem · 1

    OUR REP. IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE JAWS OF THE EXPRESSEW GUN WERE NOT OPENING EASILY, WAS HARD TO CLOSE, AND WAS NOT FIRING SMOOTHLY; WHILE ACTUATING THE NEEDLE IN THE BODY, A PORTION OF THE DISTAL TIP OF A MITEK EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLES BROKE OFF INTO THE PATIENT¿S JOINT SPACE. THEY WERE ABLE TO LOCATE AND REMOVE THE FRAGMENT, AND THE REPAIR WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE NEEDLE WAS DISCARDED AT THE USER FACILITY, BUT THE GUN IS COMING BACK. ALSO SEE ASSOCIATED MDR 1221934-2013-00187.

    Description of Event or Problem · 1

    OUR REP. IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE JAWS OF THE EXPRESSEW GUN WERE NOT OPENING EASILY, WAS HARD TO CLOSE, AND WAS NOT FIRING SMOOTHLY; WHILE ACTUATING THE NEEDLE IN THE BODY, A PORTION OF THE DISTAL TIP OF A MITEK EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLES BROKE OFF INTO THE PATIENT¿S JOINT SPACE. THEY WERE ABLE TO LOCATE AND REMOVE THE FRAGMENT, AND THE REPAIR WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE NEEDLE WAS DISCARDED AT THE USER FACILITY, BUT THE GUN IS COMING BACK. ALSO SEE ASSOCIATED MDR 1221934-2013-00187.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341293 MITEK EXPRESSEW II FLEXIBLE SUTURE PASSER ARTHROSCOPIC INSTRUMENTS LXH DEPUY MITEK NA K4249NH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR