BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD

    MDR report key: 3093900 · Received May 6, 2013

    Report

    Report Number
    1221934-2013-00125
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K070925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Additional Manufacturer Narrative · 1

    SEVENTY DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK; THE COMPLAINT DEVICE IS NOT BEING RETURNED, 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 NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF BIOKNOTLESS FOR FIXATION, A PORTION OF THE DISTAL TIP OF THE INSERTER BROKE OFF INTO THE ANCHOR WHEN THE SURGEON DEPLOYED THE ANCHOR INTO THE BONE HOLE; THE FRAGMENT REMAINS IN THE ANCHOR AND BOTH ARE CAPTURED IN THE BONE HOLE. THE PROCEDURE WAS CONCLUDED 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
    196524 MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK NA 3638588

    Patients

    Seq Age Sex Outcome Treatment
    1