BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.B.S SCREW

    MDR report key: 10827446 · Received November 12, 2020

    Report

    Report Number
    3010470577-2020-02071
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 11, 2020
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    UDI-DI
    03760225710159
    PMA / PMN Number
    K131920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD 1907223 WAS REVIEWED AND FOUND TO BE COMPLIANT. UPON INSPECTION OF THE PART, WHICH WAS RETURNED TO IN2BONES, IT APPEARS THAT THE SCREW BODY IS TWISTED AND THAT ITS DISTAL PART IS BROKEN. THE DISTAL PART OF THE SCREW WHICH BROKE DURING THE SURGERY WAS LEFT IMPLANTED, WITHOUT ANY NEGATIVE OUTCOMES FOR THE PATIENT. THE SURGERY ENDED SUCCESSFULLY WITHOUT CONSEQUENCES FOR THE PATIENT. THE OCCURRENCE FOR THIS TYPE OF INCIDENT IS ESTIMATED TO (B)(4): FOR 23 517 IBS 2.5MM COMPRESSION SCREWS SOLD WORLDWIDE, 14 WERE REPORTED TO BE TWISTED AND / OR BROKEN (SALES DATA EXTRACTED ON (B)(6), 2020). THIS FAILURE RATE IS DEEMED ACCEPTABLE. CONSIDERING THIS ACCEPTABLE FAILURE RATE, THE ABSENCE OF PATIENT CONSEQUENCES, AND THE INCIDENT ROOT CAUSE NO FIELD ACTION IS DEEMED NECESSARY. IN2BONES WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF INCIDENT AND WILL TRIGGER A FIELD ACTION IF THE OCCURRENCE AND / OR ADVERSE HEALTH OUTCOME INCREASE TO AN UNACCEPTABLE LEVEL. THE MAIN HYPOTHESIS WOULD BE THAT THE EVENT IS RELATED TO THE PATIENT BONE QUALITY (I.E. PATIENT HAVING HARD BONES) AND / OR TO AN INCORRECT USE.

    Description of Event or Problem · 1

    THE I.B.S(R) COMPRESSION AND NEUTRALIZATION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR: THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS. OSTEOSYNTHESIS REQUIRING A MONO OR BICORTICAL COMPRESSION. EVENT DESCRIPTION: AN I.B.S COMPRESSION SCREW IS REPORTED TO HAVE BROKEN DURING A BUNION SURGERY (I.E. CORRECTION OF AN HALLUX VALGUS). DESPITE THE REPORTED PROBLEM, THE SURGERY ENDED SUCCESSFULLY WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292610 I.B.S SCREW I.B.S COMPRESSION SCREW (2.5MM DIAMETER, 24MM LENGTH) HWC IN2BONES SAS S25 ST024 1907223 03760225710159

    Patients

    Seq Age Sex Outcome Treatment
    1