BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL

    MDR report key: 17735566 · Received September 13, 2023

    Report

    Report Number
    1220246-2023-07866
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 14, 2023
    Report Date
    January 16, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDQ
    UDI-DI
    00888867369887
    PMA / PMN Number
    K170206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 0

    ON 08/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 4 OF AN AR-7289T TIGERTAPE STERNAL CLOSURE WITH ATTACHED BLUNT TAPERED NEEDLE HAD AN ISSUE. THE TAPES WERE FRAYED AT THE TIP OF THE TENSIONER TO THE POINT THAT THERE WAS ONLY ONE STRAND OF SUTURE LEFT. THEY WERE NOT ABLE TO TIE A KNOW TO HOLD TENSION. THE TENSIONER DID NOT GO PAST THE 80 LINE. THE TAPES WERE REMOVED, THE PATIENT'S HEALTH WAS NOT COMPROMISED. THE DEVICES WERE DISCARDED AFTER THE CASE, AND NO PICTURES WERE TAKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/21/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THIS OCCURRED DURING A STERNAL CLOSURE CERCLAGE PROCEDURE ON (B)(6) 2023. TWO AR-7800 FIBERTAPE CERCLAGE TENSIONER, REUSABLE DID NOT GOT PAST THE 80 LINE, ONE DEVICE WITH LOT NUMBER 051912 AND ONE DEVICE WITH LOT NUMBER 051650. NO PIECES OF THE TENSIONERS BROKE, BUT THE FIBERTAPE TAIL THAT SITS IN THE TOP SLOT OF THE TENSIONER. ALL FRAGMENTS OF THE FIBERTAPES WERE REMOVED. THE CASE WAS COMPLETED BY PULLING THE FIBERTAPES OUT AND USING WIRES AND PLATES TO CLOSE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84901 TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL FIXATION CERCLAGE JDQ ARTHREX, INC. TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL 13410057 00888867369887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other