BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT

    MDR report key: 11207556 · Received January 21, 2021

    Report

    Report Number
    0002936485-2021-00044
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    December 23, 2020
    Report Date
    March 9, 2021
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    UDI-DI
    37613327176927
    PMA / PMN Number
    K170098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: GOOD AFTERNOON - I WANTED TO REACH OUT WITH SOME ISSUES WE HAVE BEEN HAVING WITH ICONIX ANCHORS USED IN OKLAHOMA CITY. WE ARE USING ICONIX 1TT IN HIP SCOPE LABRAL REPAIR CASES. RECENTLY WE HAVE BEEN SEEING FORKS BREAK OFF ON THE INSERTER AND STAYING IMPLANTED IN PILOT HOLES, ANCHORS NOT DEPLOYING (EVEN IN SOFT BONE), AND SUTURE NOT SLIDING WITHIN THE ANCHOR SHEETH AFTER DEPLOYMENT. THIS IS ONE OF OUR LARGEST VOLUME DOCTORS AND WE ARE IN NEED OF SOME ANSWERS (AND POSSIBLY A PI#) TO ADDRESS THESE ISSUES WITH HIM. I HAVE ATTACHED BELOW THE LOTS AND ITEM NUMBER BELOW. ADDITIONALLY, I WANTED TO MAKE YOU AWARE OF AN ISSUE WITH FLOWPORT (SMITH & NEPHEW) COMING IN THE PACKAGING DISASSEMBLED. THIS HAPPENED TODAY AND I HAVE ATTACHED THE PHOTO OF THE FLOWPORT AND LOT INFORMATION. *THIS PI WILL BE SPLIT OUT. PLEASE SEE PI 2602454 FOR FLOWPORT COMPLAINT. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE: 1) USE OF EXCESSIVE FORCE, 2) MOVEMENT OF GUIDE OUT OF ORIENTATION TO PILOT HOLE, OR 3) USE OF WRONG DRILL. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FORK ON THE INSERTER BROKE AND REMAINS IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FORK ON THE INSERTER BROKE AND REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107753 ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE UNK 37613327176927

    Patients

    Seq Age Sex Outcome Treatment
    1 Other