BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ARTHROSCOPIC EQUIPMENT

    MDR report key: 3021419 · Received March 26, 2013

    Report

    Report Number
    1221934-2013-00076
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP CORRESPONDENCE WITH THE SALES REP REVEALED THE DEVICE IS NOT BEING RETURNED AND IS UNAVAILABLE FOR PHYSICAL EVALUATION. 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 TWO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF 2995 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. IT IS POSSIBLE THAT THE NEEDLE WAS PASSED THROUGH EXCESS TISSUE CAUSING THE NEEDLE TO FATIGUE AND BREAK. 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.

    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

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED ON THE FDA MEDWATCH REPORT: DURING SHOULDER SURGERY, THE EXPRESSEW SUTURE NEEDLE BROKE OFF DURING THE CASE BUT THE TIP WAS RETRIEVED. ACCORDING TO THE SURGEON'S NOTE: "THERE WAS NO EVIDENCE OF ANY RETAINED NEEDLE FRAGMENTS ON ANTERIOR-POSTERIOR AND LATERAL FLUOROSCOPIC EXAM." NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123082 MITEK ARTHROSCOPIC EQUIPMENT ANCHOR INSTRUMENTS LXH DEPUY MITEK NA A209029

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR