BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK 4.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD

    MDR report key: 4838621 · Received June 11, 2015

    Report

    Report Number
    1221934-2015-00823
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K120449
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY SYNTHES MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY SYNTHES MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. IN TRANSIT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. FROM PAST INVESTIGATIONS, THIS FAILURE IS USUALLY CONSISTENT WITH EXCESS TORQUE BEING APPLIED ON THE INSERTER WHILE IMPLANTING THE ANCHOR. 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 WITH ONE UNRELATED INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES 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. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. HOWEVER, DEPUY SYNTHES 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

    THE SALES REP REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE TIP OF A 4.5MM HEALIX ADVANCE PEEK ANCHOR(222303) INSERTER BROKE OFF IN THE ANCHOR AS THE SURGEON TRIED TO RETRACT IT FROM THE PATIENT. THE SURGEON REMOVED THE BROKEN PIECE OF TIP ALONG WITH THE ANCHOR FROM THE PATIENT. THE SURGEON INSERTED A 4.5MM HEALIX ADVANCE PEEK ANCHOR (222304) IN THE SAME BONE HOLE AND THE TIP OF THIS INSERTER BROKE OFF IN THE ANCHOR. THE SURGEON LEFT THE INSERTER TIP FRAGMENT CONTAINED WITHIN THE ANCHOR IN THE PATIENT. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE DUE TO THE PROBLEMS WITH THE COMPLAINT DEVICES, WITH NO REPORTED ADVERSE PATIENT CONSEQUENCES. SEE ASSOCIATED MEDWATCH # 1221934-2015-00824.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE TIP OF A 4.5MM HEALIX ADVANCE PEEK ANCHOR¿S (B)(4) INSERTER BROKE OFF IN THE ANCHOR AS THE SURGEON TRIED TO RETRACT IT FROM THE PATIENT. THE SURGEON REMOVED THE BROKEN PIECE OF TIP ALONG WITH THE ANCHOR FROM THE PATIENT. THE SURGEON INSERTED A 4.5MM HEALIX ADVANCE PEEK ANCHOR (B)(4) IN THE SAME BONE HOLE AND THE TIP OF THIS INSERTER BROKE OFF IN THE ANCHOR. THE SURGEON LEFT THE INSERTER TIP FRAGMENT CONTAINED WITHIN THE ANCHOR IN THE PATIENT. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE DUE TO THE PROBLEMS WITH THE COMPLAINT DEVICES, WITH NO REPORTED ADVERSE PATIENT CONSEQUENCES. SEE ASSOCIATED MEDWATCH # 1221934-2015-00824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381289 MITEK 4.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD ANCHOR IMPLANTS HWC DEPUY MITEK NA 3778378

    Patients

    Seq Age Sex Outcome Treatment
    1