BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK CORD CUTTER

    MDR report key: 3772920 · Received April 25, 2014

    Report

    Report Number
    1221934-2014-00158
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE RETURNED DEVICE SHOWS NO ANOMALIES AND IS FULLY INTACT. THE DEVICE IS NOT BROKEN AS REPORTED. FOLLOW UP WITH THE SALES REP REGARDING THE COMPLAINT DEVICE DID NOT YIELD ANY FURTHER INFORMATION. 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, THIS COMPLAINT CANNOT BE CONFIRMED OR A ROOT CAUSE FOR THE USER TO HAVE EXPERIENCED THE REPORTED FAILURE CANNOT BE DISCERNED. NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ADDITIONAL INFORMATION BE PROVIDED TO MITEK AT ANY TIME IN FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. 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 SALES REP REPORTED THAT DURING A SHOULDER REPAIR, THE METAL TIP BROKE OFF HIS CORD CUTTER INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON RETRIEVED IT AND NO X-RAYS WHERE NEEDED. THE SURGEON WAS CUTTING THE LAST SUTURE WHEN THE DEVICE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP REPORTED THE DEVICE DID NOT HIT BONE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER BUT REPORTED THAT THE DEVICE WAS ABOUT 8 YEARS OLD AND HAD NOT SEEN HEAVY USE. THE DEVICE IS BEING RETURNED FOR EVALUATION. THE LOT NUMBER OF THE COMPLAINT DEVICE WAS CONFIRMED TO BE 12K08 AT THE TIME THE DEVICE WAS RECEIVED BY MITEK COMPLAINTS ON (B)(4) 2014.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR, THE METAL TIP BROKE OFF HIS CORD CUTTER INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON RETRIEVED IT AND NO X-RAYS WHERE NEEDED. THE SURGEON WAS CUTTING THE LAST SUTURE WHEN THE DEVICE BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP REPORTED THE DEVICE DID NOT HIT BONE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER BUT REPORTED THAT THE DEVICE WAS ABOUT 8 YEARS OLD AND HAD NOT SEEN HEAVY USE. THE DEVICE IS BEING RETURNED FOR EVALUATION. THE LOT NUMBER OF THE COMPLAINT DEVICE WAS CONFIRMED TO BE 12K08 AT THE TIME THE DEVICE WAS RECEIVED BY MITEK COMPLAINTS ON APRIL 9, 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251813 MITEK CORD CUTTER ARTHROSCOPIC SUTURE CUTTER GEF DEPUY MITEK NA 12K08

    Patients

    Seq Age Sex Outcome Treatment
    1