BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VERSALOK TI ANCHOR, THREADER TAB W/O SUTURE

    MDR report key: 2509738 · Received March 29, 2012

    Report

    Report Number
    1221934-2012-00077
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 26, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K063478
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    THE VERSALOK(TI) ANCHOR SYSTEM 210800 AND FAMILY WAS UPGRADED TO AVOID THE DEPLOYMENT "CLICK" THAT CAUSES POTENTIAL PERFORMANCE ISSUES SUCH AS NON-DEPLOYMENT OF ANCHOR, AND WEAR TO VERSALOK'S DEPLOYMENT GUN. MANY OF THE CHANGES TO THE INSERTER SUBASSEMBLY ARE REFLECTIVE OF THE VERSALOK PEEK INSERTER SUBASSEMBLY, WHICH WAS DESIGNED TO DEPLOY THE ANCHOR WITHOUT A "CLICK" . THIS DESIGN CHANGES TO VERSALOK TI FAMILY OF PRODUCTS WAS IMPLEMENTED IN (B)(6) 2011. THIS DEVICE THAT WAS RETURNED FROM THE FIELD IS THE OLD DESIGN. THE NON-DEPLOYMENT ISSUE WAS RESOLVED AND FIXED (B)(4). 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, THE SURGEON WAS ATTEMPTING TO DEPLOY A VERSALOK ANCHOR FOR FIXATION, HOWEVER, THE ANCHOR WOULD NOT DEPLOY FORM ITS INSERTER. THE SURGEON WAS ABLE TO REMOVE THE ANCHOR/INSERTER ASSEMBLY AND FIXATED USING ANOTHER DEVICE. THE PROCEDURE WAS EXTENDED BY 40 MINUTES BECAUSE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VERSALOK TI ANCHOR, THREADER TAB W/O SUTURE SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA 3523957

    Patients

    Seq Age Sex Outcome Treatment
    1