BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3925630 · Received July 10, 2014

    Report

    Report Number
    1221934-2014-00287
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NEEDLE 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. NO FURTHER PROCEDURE INFORMATION WAS PROVIDED TO DETERMINE IF THE AFOREMENTIONED CAUSES CONTRIBUTED TO THIS FAILURE. TWO BATCH NUMBERS A401001 AND A401026 WERE PROVIDED FOR THIS NEEDLE AS THE CUSTOMER WAS UNSURE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THE BATCH A401001 WAS PROCESSED WITH TWO UNRELATED NCS WITH NO LINK TO THIS COMPLAINT. BATCH A402026 WAS ALSO PROCESSED WITH AN UNRELATED NC WITH NO LINK TO THIS COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FROM EITHER OF THESE BATCHES FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THESE TWO BATCHES OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE OVERALL COMPLAINT RATE AND CUSTOMER IMPACT, 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.

    Description of Event or Problem · 1

    THE TIP OF THE EXPRESSEW III NEEDLE BROKE OFF. SURGEON DOES NOT KNOW IF IT BROKE IN PATIENT OR DURING LOADING OF NEEDLE. DID X-RAY ON PATIENT AND NO METAL WAS IN THE SHOULDER. THEY COULD NOT FIND THE TIP IN PATIENT, ON PATIENT, ON THE SURGICAL FIELD. COULD HAVE BEEN SUCKED UP IN THE SUCTION CANISTERS. LOADED ANOTHER EXPRESSEW III NEEDLE IN THE DEVICE AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404177 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURE PASSER NEEDLE LXH DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1