BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3031481 · Received April 2, 2013

    Report

    Report Number
    1221934-2013-00088
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 2, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.

    Additional Manufacturer Narrative · 1

    FIFTY-SEVEN DAYS HAVE PASSED AND THE COMPLAINT DEVICE HAS NOT BEING RECEIVED, WHICH PRECLUDES CONDUCTING AN EVALUATION; HOWEVER, A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR 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 3 OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT ARE FROM THE SAME SURGEON AND FACILITY AS THIS ISSUE. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, 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

    THIS COMPLAINT WAS ORIGINALLY CLOSED ON MAY 29, 2013; 51 DAYS HAD PASSED AND THE COMPLAINT DEVICE HAD NOT BEEN RECEIVED; HOWEVER, THE COMPLAINT DEVICE HAS JUST RECENTLY ARRIVED (AUGUST 8, 2013) FOR EVALUATION. THE DEVICE HAS BEEN RECEIVED AND EVALUATED VISUALLY, BOTH WITH THE NAKED EYE AND UNDER POWER: IT IS NOTED THAT THE DEVICE IS IN THE COMPLAINED ABOUT CONDITION, A PORTION OF THE DISTAL TIP IS MISSING. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR 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 4 OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES, 3 OF WHICH ARE FROM THE SAME SURGEON AND FACILITY AS THIS ISSUE. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. IT IS POSSIBLE THAT THE USER MAY HAVE HIT SOME HARD OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES AND CONSIDERATIONS, NO OTHER ROOT OR UNDERLYING CAUSE CAN BE DISCERNED. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, 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

    OUR AFFILIATE REPORTED TO US THAT THE DISTAL TIP OF AN EXPRESSEW III NEEDLE BROKE OFF AND FELL INTO THE PATIENT DURING AN UNDEFINED PROCEDURE. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134484 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA A208027

    Patients

    Seq Age Sex Outcome Treatment
    1