BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AKILINK MINI INVASIVE ACHILLES TENDON REPAIR SYSTEM

    MDR report key: 23107270 · Received September 22, 2025

    Report

    Report Number
    3010470577-2021-05041
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    April 20, 2021
    Report Date
    September 22, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HCF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD IS REVIEWED AND FOUND TO BE COMPLIANT 69 PRODUCTS WERE RELEASED ON MAY 28TH, 2020. PRODUCT NOT YET RETURNED, BUT PICTURES PROVIDED THE DEFECT IS CONFIRMED, AND COHERENT WITH THE EVENT DESCRIPTION REPORTED BY THE INITIATOR : THE BREAKAGE HAPPENED BECAUSE THE USER TRIED TO EXPAND THE HANDLE ARMS BY HAND BY PULLING ON THEM, THUS OPENING THEM FURTHER THAN POSSIBLE AND LEADING TO THE INSTRUMENT BREAKAGE. THE EVENT IS RELATED TO A USER ERROR: THE HANDLE ARMS ARE TO BE OPENED BY PUSHING THE HANDLE BUTTON ONLY, AND SHALL NOT BE OPENED BY PULLING ON THE ARMS BY HAND. A DESIGN CHANGE (DM1904-12) IS BEING IMPLEMENTED IN ORDER TO ADD INTERNAL STOP IN THE HANDLE PREVENTING THE USER TO REALIZE AN EXCESSIVE ARMS OPENING.

    Description of Event or Problem · 0

    THE AKILINK MINI INVASIVE ACHILLES TENDON REPAIR SYSTEM IS A SINGLE USE INSTRUMENTS SET PROVIDED STERILE, INTENDED TO BE USED TO TREAT ACUTE CLOSED ACHILLES TENDON RUPTURES. IT IS USED DURING MINIMALLY INVASIVE PROCEDURES AND ALLOWS DIRECT VISUAL CONTROL OF THE REPAIR, AS WELL AS PERCUTANEOUS INTRODUCTION OF THE SUTURES. THE SURROUNDING SOFT TISSUES AND TENDON ITSELF ARE ALWAYS TREATED WITH THE UTMOST CARE TO AVOID ANY LOCAL TRAUMA. THE AKILINK MINI INVASIVE ACHILLES TENDON REPAIR SYSTEM INCLUDES: - ONE ASSEMBLED HANDLE INSTRUMENT MADE OUT OF IXEF AND 316L STAINLESS STEEL; - ONE LATERAL EXTENSION MADE OUT OF IXEF; - ONE NEEDLE PUSHER MADE OUT OF POLYCARBONATE; - TWO NEEDLES MADE OUT OF STAINLESS STEEL 316L IN ACCORDANCE WITH ASTM F138-139 AND ISO 5832-1 STANDARDS. NO IMPLANTABLE DEVICE IS PROVIDED IN THE AKILINK SET: THE SUTURES INTENDED TO BE USED TO CLOSED THE TENDON RUPTURE ARE NOT AVAILABLE IN THE AKILINK SET. THE AKILINK SYSTEM IS SINGLE USE AND IS INTENDED TO BE USED FOR A SINGLE PATIENT DURING A SINGLE SURGERY; IT IS NOT INTENDED TO BE REPROCESSED. -------------------------------------------- EVENT DESCRIPTION: AS REPORTED BY THE COMPLAINT INITIATOR (N. LAW EMAIL DATED ON 04/MAY/2021): "AS PER OUR DOCTOR REPORTED RECENTLY, PART OF AKILINK TENDON REPAIR DEVICE, THE TRIANGLE PLASTIC PART ILLUSTRATED IN THE PHOTO, HAS BEEN BROKEN AND LOOSENED DURING OPERATION ON (B)(6) 2020." ADDITIONAL INFORMATION RECEIVED ON MAY 17TH, 2021: "THE SURGEON FOUND THE BLADE WIDTH IS NOT ENOUGH SO HE OPENED THE BLADES BIGGER BY HAND. OTHERWISE, THE BLADES CANNOT BE INSERTED INTO THE WOUND, BUT THE TRIANGLE PLASTIC PART BROKE OFF FROM THE DEVICE. THE SURGEON CHANGED ANOTHER NEW AKILINK DEVICE FOR THE SURGERY, BUT HE MUST OPEN THE BIGGER WOUND TO INSERT THE BLADES INTO THE TENDON". ADDITIONAL INFORMATION (N. LAW E-MAIL DATED ON MAY 17TH, 2021): . THE ORIGINAL REQUEST IS OPENED A HOLE FOR THE SURGERY. FINALLY, THE PATIENT'S WOUND IS BIGGER AND LONGER. THE SURGERY DURATION IS LONGER, BUT NOT SIGNIFICANT INCREASE. . THE SURGERY HAS BEEN SUCCESSFULLY FINISHED THE CASE WITH ANOTHER AKILINK DEVICE. THIS REPORTABLE EVENT IS PART OF A REMEDIATION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070750 AKILINK MINI INVASIVE ACHILLES TENDON REPAIR SYSTEM AKILINK HCF IN2BONES SAS 2002168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization