BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.B.S SCREW

    MDR report key: 17754723 · Received September 15, 2023

    Report

    Report Number
    3010470577-2022-11161
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    September 11, 2022
    Report Date
    August 3, 2023
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    UDI-DI
    03760225711811
    PMA / PMN Number
    K131920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SCREWS: BATCH RECORDS WAS REVIEWED AND FOUND TO BE COMPLIANT. THE PRODUCT WAS RELEASED ON DECEMBER 2020. THIS EVENT IS THE FIRST COMPLAINT INVOLVING AN IMPLANT OF THIS BATCH. A GLOBAL REVIEW OF ALL COMPLAINTS RELATED TO I.B.S COMPRESSION AND NEUTRALIZATION SCREWS REPORTED WITH A BROKEN SCREW (ALL BREAKAGES TYPES IN THE FOREFOOT AREA) WAS PERFORMED. SINCE THE INITIAL MARKETING OF THE RANGE IN 2012, 15 SCREWS WERE REPORTED BROKEN WHEN USED IN THE FOREFOOT FOR (B)(4) SCREWS SOLD WORLDWIDE (UP TO MAY 1ST,2023). THE FAILURE RATE IS THUS ESTIMATED TO (B)(4), AND THE SEVERITY CORRESPONDING TO THE COMPLAINT IS "MODERATE". THE RESULTING HEALTH RISK INDEX (HRI) SCORE IS DEEMED ACCEPTABLE AS PER IN2BONES INTERNAL HRI EVALUATION PROCEDURE (SOP PAR04). THE DEVICE WAS NOT RETURNED TO IN2BONES SINCE IT WAS DISCARDED. SHOULD ANY OTHER INFORMATION ARISE, IN2BONES WILL UPDATE THIS REPORT.

    Description of Event or Problem · 0

    THE I.B.S.¿ COMPRESSION AND NEUTRALIZATION OSTEOSYNTHESIS SCREWS ARE USED IN FOREFOOT ORTTHOPAEDIC SURGERY AND 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 : INITIAL INFORMATION REPORTED BY A DISTRIBUTOR ON (B)(6), 2022: "THEY REALIZED THAT THE SCREW LOCATION WAS TOO DORSAL AND LOOKED BENT AS WELL ON X-RAY. ONCE THEY GOT THE SCREW OUT, THE BOTTOM OF SCREW BROKE OFF. I ADDED IMAGES THAT I TOOK THAT DAY OF THE DRIVER THAT BROKE, THE SCREW ONCE IT CAME OUT, AND THE X-RAY OF IBS SCREWS WHEN FIRST IMPLANTED. SURGEON ENDED UP USING TWO 4.0 SCREWS TO COMPLETE THE CASE (AFTER TAKING OUT IBS SCREWS) AND WAS CONTENT WITH SCREW PLACEMENT." THE SURGERY ENDED SUCCESSFULLY AFTER A SIGNIFICANT DELAY IN SURGERY DURATION; ANY CONSEQUENCES FOR THE PATIENT. IT IS CONSIDERED THAT IF THE EVENT WERE TO HAPPEN AGAIN IT COULD CAUSE A SERIOUS INJURY TO THE PATIENT AND IS THUS TO BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290216 I.B.S SCREW I.B.S® 3.5-C COMPRESSION SCREW - DIAM 3.5MM LG32MM, PRODUCT HWC IN2BONES SAS S35 ST132 2011038 03760225711811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other