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: 11496037 · Received March 16, 2021

    Report

    Report Number
    0002936485-2021-00144
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 17, 2021
    Report Date
    April 27, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: LAST WEDNESDAY WE HAD A SIMILAR OCCURRENCE WITH AN ICONIX 1TT INSERTER TIP BREAKING OFF AND LODGING IN THE PILOT HOLE. THE IMPLANT STAYED PUT AND THE SUTURE SLID JUST FINE. I AM GOING TO SEND THE BROKEN INSERTER FOR YOUR RECORDS AS SOON AS POSSIBLE. 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. THE DEVICE MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394749 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