BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK EXPRESSEW II NEEDLE

    MDR report key: 3854539 · Received June 6, 2014

    Report

    Report Number
    1221934-2014-00218
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. NO FURTHER PROCEDURE INFORMATION WAS PROVIDED TO DETERMINE IF THE ABOVE REASONS CONTRIBUTED TO THIS FAILURE. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. 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 NEEDLE WAS BROKEN DURING THE SURGERY. IT WAS NOTED THAT THE BROKEN PIECE WAS LEFT IN THE PATIENT'S BODY. IT IS NOT REPORTED HOW THE SURGERY WAS COMPLETED. FARTHER INFORMATION WILL BE PROVIDED AS SOON AS JJKK RECEIVE IT FROM THE FACILITY. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE WAS BROKEN DURING THE SURGERY. IT WAS NOTED THAT THE BROKEN PIECE WAS LEFT IN THE PATIENT¿S BODY. IT IS NOT REPORTED HOW THE SURGERY WAS COMPLETED. FARTHER INFORMATION WILL BE PROVIDED AS SOON AS (B)(4) RECEIVE IT FROM THE FACILITY. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332290 MITEK EXPRESSEW II NEEDLE ARTHROSCOPIC SUTURE NEEDLE LXH DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1