BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK LUPINE LOOP RAPIDE (BR) ANCHOR W/ORTHOCORD

    MDR report key: 2970211 · Received February 20, 2013

    Report

    Report Number
    1221934-2013-00046
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 14, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K070925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK THROUGH AN ADVERSE EVENT REPORT AUTHORED BY THE USER FACILITY AND FORWARDED TO US THROUGH (B)(6). WHILE THE COMPLAINT REPORT TALKS ABOUT "METAL SHAVINGS" THAT WERE APPARENT IN THE BODY, THE REPORT REFERS TO SOME MITEK ANCHORS AS THE COMPLAINT DEVICES; THESE ANCHORS ARE CONSTRUCTED OF A POLYMER, A PLASTIC IF YOU WILL. THE ASSOCIATION OF "METAL SHAVINGS" TO "POLYMER" MATERIAL IS NOT REASONABLE, AND SO, OUR (B)(4) AFFILIATE HAS ACTED IN GOOD FAITH AS OUR AGENT IN AN EFFORT TO CLARIFY THIS DISCREPANCY WITH THE REPORTING FACILITY, TO DATE WITHOUT SUCCESS. DESPITE MANY OUTREACHES FOR FURTHER DETAIL AND CLARITY, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. A BATCH RECORD REVIEW FOR THE REPORTED DEVICES 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 THE 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 NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT ASSOCIATE THE REPORTED ISSUE TO THE REPORTED DEVICE, AND WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. 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

    MITEK RECEIVED AN ADVERSE EVENT REPORT FROM THE (B)(4) WHICH WAS AUTHORED BY THE USER FACILITY. THE FACILITY IS NOTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, "METALLIC SHAVINGS" OR "FOREIGN DEBRIS" WAS OBSERVED IN THE PATIENT'S JOINT SPACE WHILE MITEK LUPINE DEVICES WERE BEING USED FOR FIXATION. THEY WERE NOT ABLE TO REMOVE ALL OF THE DEBRIS; HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. AT THIS POINT IN TIME, OUR (B)(4) AFFILIATE HAS CONTACTED THE FACILITY TOWARDS GAINING FURTHER DETAIL AND CLARITY OF THE ISSUE. THE ISSUE. ALSO SEE ASSOCIATED MDRS 1221934-2013-00044 AND 1221934-2013-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73873 MITEK LUPINE LOOP RAPIDE (BR) ANCHOR W/ORTHOCORD SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK NA 3623524

    Patients

    Seq Age Sex Outcome Treatment
    1