BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.B.S SCREW

    MDR report key: 10827498 · Received November 12, 2020

    Report

    Report Number
    3010470577-2020-02091
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    January 24, 2020
    Report Date
    May 20, 2020
    Manufacturer
    IN2BONES SAS
    Product Code
    HXX
    PMA / PMN Number
    K131920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORDS (IN2BONES BATCH NUMBER 1705026 AND 1507100) WERE REVIEWED AND FOUND TO BE COMPLIANT. VISUAL INSPECTION DONE ON THE INSTRUMENTS PICTURES SENT BY THE COMPLAINT INITIATOR: BOTH SCREWDRIVERS TIP IS TWISTED. NO BROKEN PART VISIBLE. ONE SCREWDRIVER SEEMS TO HAVE BEEN TWISTED WHILE IMPLANTING A SCREW AND THE SECOND ONE APPEARS TO HAVE BEEN DAMAGED WHILE REMOVING A SCREW. THE RETURN OF THE INVOLVED INSTRUMENTS AT IN2BONES HAS BEEN REQUESTED FOR ADDITIONAL ANALYSIS. THIS IS THE FIRST REPORTED OCCURRENCE OF A SCREWDRIVER DAMAGED DURING SURGERY LEADING TO A SIGNIFICANT INCREASE OF THE SURGERY DURATION. A GLOBAL REVIEW OF ALL THE REPORTED CASES OF T15 REUSABLE SCREWDRIVERS FAILURES SHOWED THAT THIS DEFECT IS ASSOCIATED TO A FAILURE RATE OF 0.14% AND A SEVERITY QUOTED AS "MINOR"; WHICH ARE DEEMED ACCEPTABLE AS PER IN2BONES INTERNAL HEALTH RISK INDEX EVALUATION (SOP PAR04). CALCULATION DETAILS: NUMBER OF INVOLVED T15 REUSABLE TWISTED AND / OR BROKEN SCREWDRIVERS INVOLVED IN COMPLAINTS / NUMBER OF SCREWS IMPLANTED THANKS TO T15 REUSABLE SCREWDRIVERS.

    Description of Event or Problem · 1

    THE I.B.S 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. THE 4.5MM DIAMETER SCREWS ARE TO BE IMPLANTED THANKS TO T15 REUSABLE SCREWDRIVERS. EVENT DESCRIPTION: DURING A PATELLA SURGERY, THE TIP OF TWO REUSABLE T15 SCREWDRIVERS TWISTED, LEADING THE SURGEON TO USE MORE STRENGTH THAN USUAL TO IMPLANT THE SCREWS. THE SURGERY ENDED SUCCESSFULLY WITHOUT ANY CONSEQUENCES FOR THE PATIENT. THIS EVENT IS REPORTABLE, SINCE THE DISTRIBUTOR ESTIMATED THAT IT INDUCED A SIGNIFICANT INCREASE IN THE SURGERY DURATION (ESTIMATED TO BE OF MORE THAN 30 MINUTES BUT LESS THAN ONE HOUR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292611 I.B.S SCREW TORX T15 REUSABLE SCREWDRIVERS HXX IN2BONES SAS G01 00331 & G01 00361 1507100 & 1705026

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR