BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSALOK PREPACKED ANCHOR WITH ORTHOCORD

    MDR report key: 2041904 · Received March 30, 2011

    Report

    Report Number
    1221934-2011-00135
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, IS UNAVAILABLE FOR A PHYSICAL EVAL. 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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. SHOULD MITEK EVER RECEIVE THE COMPLAINT DEVICE, AN EVAL WILL BE PERFORMED TO TRY AND DETERMINE ROOT CAUSE FOR THE REPORTED FAILURE MODE. SHOULD A ROOT CAUSE BE DETERMINED, OR SHOULD THERE BE A CHANGE IN THE PT'S STATUS, MITEK WILL FILE A FOLLOW-UP REPORT AT THAT TIME.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE SURGEON INSERTED A VERSALOK ANCHOR INTO THE PT. UPON REMOVING THE VERSALOK GUN, THE ANCHOR LOOSENED WHILE THE SURGEON TRIED REMOVING THE INSERTER SHIFT FROM THE ANCHOR. THE SURGEON CHANGED FROM AN ARTHROSCOPIC PROCEDURE TO AN OPEN PROCEDURE WHICH EXTENDED THE PROCEDURE BY THIRTY MINUTES. THE SUTURES WERE CUT AND THE FAILED ANCHOR WAS REMOVED FROM PT. LEAVING THE MEDIAL ROW INTACT ONLY. UPON CLOSER EXAMINATION OF THE ANCHOR, THE SURGEON FOUND THAT THE PEEK SLEEVE HAD CRACKED. IT IS NOT KNOWN WHAT WAS DONE TO COMPLETE THE PROCEDURE, AND THERE HAVE BEEN NO REPORTS OF ADVERSE HARM OR CONSEQUENCE TO THE PT OTHER THAN THE CONVERSION TO AN OPEN PROCEDURE, FOR WHICH WE ARE REPORTING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALOK PREPACKED ANCHOR WITH ORTHOCORD SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210808 3432793

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention