BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK HEALIX PEEK ANCHOR, 6.5MM W/ORTHOCORD

    MDR report key: 2895240 · Received January 3, 2013

    Report

    Report Number
    1221934-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K071481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTY-SIX DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, ALTHOUGH IT WAS ORIGINALLY INDICATED THAT SOMETHING WOULD BE RETURNED, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. 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 COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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. DEVICE EVALUATED BY MFR: AWAITING SAMPLES.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT THE SURGEON HAD SOME ISSUES WHILE TYING DOWN SOME SUTURE. THE PATIENT WAS UNDERGOING AN ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF 2 HEALIX PEEK ANCHORS FOR FIXATION. AFTER INSERTION INTO THEIR BONE HOLES AND WILE TYING DOWN THEIR SUTURE, THE SUTURES BROKE; THIS HAPPENED ON BOTH DEPLOYED ANCHORS (ANCHORS LEFT SECURELY IN THE BONE). THE SURGEON USED S&N TWINFIX ANCHORS TO COMPLETE THE REPAIR. THEY ARE REPORTING THAT THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. HOWEVER, THERE WAS A 50 MINUTE ADD ON TO THE SURGERY TIME BECAUSE OF THIS, WHICH IS THE REASON FOR THIS REPORT. ALSO SEE ASSOCIATED MDR 1221934-2013-00002

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2932 MITEK HEALIX PEEK ANCHOR, 6.5MM W/ORTHOCORD SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA 3623433

    Patients

    Seq Age Sex Outcome Treatment
    1