BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3831057 · Received May 23, 2014

    Report

    Report Number
    1221934-2014-00208
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE TIP OF THE NEEDLE IS BROKEN, CONFIRMING THIS COMPLAINT. FROM PAST INVESTIGATIONS OF SIMILAR FAILURE MODES, IT HAS BEEN DETERMINED THAT REPEATEDLY PASSING THE NEEDLE THROUGH EXCESS TISSUE CAUSES THE NEEDLE TO FATIGUE AND BREAK. EIII NEEDLES HAVE BEEN DESIGNED TO PASS 15 TIMES THROUGH TISSUE AND ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE. IT WAS REPORTED THAT THE NEEDLE WAS PASSED 3 TIMES WHEN IT BROKE. IT IS UNKNOWN IF THE NEEDLE ACCIDENTALLY HIT BONE DURING PASSING CAUSING IT TO BREAK. A ROOT CAUSE CANNOT BE DETERMINED AT THIS POINT. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE 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 ONE SIMILAR AND 3 DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT RATE HAS BEEN REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. BASED ON THE COMPLAINT HISTORY, NO FURTHER CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION THAT IS PERTINENT TO THIS ISSUE. DEPUY 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

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. IN PROCESS.

    Description of Event or Problem · 1

    THE TIP OF THE EXPRESSEW NEEDLE BROKE OFF DURING THE OPERATION. A C-ARM REVEALED THAT THE NEEDLE TIP WAS ENCAPSULATED IN THE TISSUE. THE SURGEON ATTEMPTED TO REMOVE THE NEEDLE TIP, BUT WAS UNABLE TO VISUALIZE IT. INSERTED SCREW. ADDITIONAL INFORMATION FROM THE SALES REP WAS THAT THE NEEDLE WAS FIRED THREE TIMES, ONE ANCHOR WAS USED FOR THE REPAIR, THE NEEDLE BROKE ON THE SECOND PASS, AND ORTHOCORD WAS USED.

    Description of Event or Problem · 1

    THE TIP OF THE EXPRESSEW NEEDLE BROKE OFF DURING THE OPERATION. A C-ARM REVEALED THAT THE NEEDLE TIP WAS ENCAPSULATED IN THE TISSUE. THE SURGEON ATTEMPTED TO REMOVE THE NEEDLE TIP, BUT WAS UNABLE TO VISUALIZE IT. INSERTED SCREW. ADDITIONAL INFORMATION FROM THE SALES REP WAS THAT THE NEEDLE WAS FIRED THREE TIMES, ONE ANCHOR WAS USED FOR THE REPAIR, THE NEEDLE BROKE ON THE SECOND PASS, AND ORTHOCORD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307884 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURE NEEDLE LXH DEPUY MITEK NA A306008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention