BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 4191029 · Received October 21, 2014

    Report

    Report Number
    1221934-2014-00455
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE TIP OF THE NEEDLE IS BROKEN, CONFIRMING THIS COMPLAINT. IT WAS ALSO OBSERVED THAT THE PROXIMAL END OF THE NEEDLE IS SLIGHTLY BENT AND MISSING THE FLAG PIECE. 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. THE SLIGHTLY BENT PROXIMAL END INDICATES THAT THE NEEDLE MIGHT NOT HAVE BEEN LOADED CORRECTLY OR FORCED INTO THE GUN, WHICH WOULD CAUSE THE NEEDLE TO NOT DEPLOY PROPERLY AND COULD CAUSE THE REPORTED FAILURE AS WELL. EIII NEEDLES HAVE BEEN DESIGNED TO PASS 15 TIMES THROUGH TISSUE AND ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE. NO FURTHER PROCEDURE INFORMATION WAS PROVIDED TO DETERMINE IF THE ABOVE REASON CONTRIBUTED TO THIS FAILURE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH ONE UNRELATED INCIDENT. THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF (B)(4) 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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE DISTAL TIP OF THE CUSTOMER'S EXPRESSEW III NEEDLE BROKE OFF WHILE PASSING SUTURE THROUGH THE ROTATOR CUFF. THE BROKEN PIECE WAS RETRIEVED. NO X-RAYS WERE NEEDED. THE SURGEON COMPLETED THE PROCEDURE WITH A COMPETITOR'S DEVICE WITH NO PATIENT CONSEQUENCES. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE. THE SALES REP REPORTED THAT THE SURGEON WAS USING THE EXPRESSEW AUTOCAPTURE AND HAD FIRED THE GUN 10 TIMES BEFORE THE NEEDLE BROKE. THE SALES REP REPORTED THE BROKEN PIECE WAS 4MM. THE SALES REP REPORTED THAT THE SURGEON WAS USING #2 ORTHOCORD AND #2 PERMACORD.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE DISTAL TIP OF THE CUSTOMER'S EXPRESSEW III NEEDLE BROKE OFF WHILE PASSING SUTURE THROUGH THE ROTATOR CUFF. THE BROKEN PIECE WAS RETRIEVED. NO X-RAYS WERE NEEDED. THE SURGEON COMPLETED THE PROCEDURE WITH A COMPETITOR'S DEVICE WITH NO PATIENT CONSEQUENCES. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE. THE SALES REP REPORTED THAT THE SURGEON WAS USING THE EXPRESSEW AUTOCAPTURE AND HAD FIRED THE GUN 10 TIMES BEFORE THE NEEDLE BROKE. THE SALES REP REPORTED THE BROKEN PIECE WAS 4MM. THE SALES REP REPORTED THAT THE SURGEON WAS USING #2 ORTHOCORD AND #2 PERMACORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669930 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURE PASSER NEEDLE LXH DEPUY MITEK NA A404033

    Patients

    Seq Age Sex Outcome Treatment
    1