BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE ® II BTB WITH DEPLOYING SUTURE

    MDR report key: 19435915 · Received May 31, 2024

    Report

    Report Number
    1220246-2024-04541
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    September 16, 2021
    Report Date
    May 31, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 9/21/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE WHEN TENSION THE FEMORAL SIDE OF THE BTB GRAFT IT SEEMED AS THOUGH THERE WAS STILL SLACK IN THE MECHANISM. THE SURGEON PULLED ON THE DISTAL END OF THE GRAFT AND THERE WAS ROUGH 4-5MM OF "CREEP" THAT COULD BE OBSERVE. THE SURGEON THEN HAD HIS FELLOW HOLD TENSION ON THE DISTAL END OF THE GRAFT WHILE HE ATTEMPTED TO PULL EACH TENSIONING SUTURE INDIVIDUALLY TO REDUCE THE CREEP. EACH TIME HE FINISHED HE WOULD CHECK AGAIN BY PULLING DISTALLY ON THE GRAFT AND THE GRAFT WOULD COME BACK 4-5 MM. HE CONFIRMED THE BUTTON WAS NOT SITTING ON THE IT BAND. THIS WAS DISCOVERED DURING AN ACL/PCL / RECONSTRUCTION ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 9/22/2021 IMPLANT WAS NOT REMOVED AND REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312045 TIGHTROPE ® II BTB WITH DEPLOYING SUTURE TIGHTROPE ® II BTB WITH DEPLOYING SUTURE MBI ARTHREX, INC. TIGHTROPE ® II BTB WITH DEPLOYING SUTURE 12825400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown