BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLOCK T8 AO SCREWDRIVER TIP

    MDR report key: 10911396 · Received November 26, 2020

    Report

    Report Number
    3010673777-2020-00004
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 5, 2020
    Manufacturer
    NOVASTEP
    Product Code
    HRS
    UDI-DI
    03700879500980
    PMA / PMN Number
    K143523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF THE PATIENT AND THE SURGERY : NO PATIENT'S DATA AVAILABLE NO DATA AVAILABLE CONCERNING THE ID OF THE IMPLANTS USED FOR THAT SURGERY THE BREAKAGE HAPPENED "AT THE END OF SCREWING IN". THE TIP REMAINED "FLUSH IN THE SCREW" WHICH MEANS NO RISK OF TISSUE DAMAGE THE SURGERY WAS PERFORMED SUCCESSFULLY PATIENT FOLLOW-UP NOT DETERMINED AT THIS DATE DESCRIPTION OF THE PRODUCT : THE DEVICE IS A NON-CANNULATED SCREWDRIVER WITH T8 TORX TIP. TRACKABILITY OF THE BATCH: BATCH NUMBER B00104: (B)(4). THE RESPONSIBLE DEVICE MUST BE ONE OF THEM, SO IT IS PROBABLY ON THE MARKET SINCE MORE THAN 5 YEARS. WE CAN'T CONFIRM THAT IT HAS BEEN USED FOR THAT PERIOD OF TIME. THE INCIDENT MIGHT HAVE HAPPENED AT ITS FIFTH OR SIXTH USE ONLY. VERIFICATION OF THE MANUFACTURING RECORD : MANUFACTURED IN SEPTEMBER 2014. NO DEVIATION TO SPECIFICATIONS OBSERVED AT RECEPTION. REVIEW OF NON-CONFORMITIES AND CUSTOMER COMPLAINTS: FIRST OCCURRENCE OF SUCH A REPORTED DEFECT FOR THAT REFERENCE. ONLY 2 NON-CONFORMITIES DETECTED, BOTH DUE TO MARKING ERRORS, WITHOUT ANY LINK TO THE CURRENT DEFECT. ANALYSIS OF PRODUCT RETURNED: NO PRODUCT RETURNED. MOREOVER, CONSIDERING THE TIME OF USE OF THE DEVICE, THE INCIDENT DOESN'T SEEM TO BE DUE TO A DEFECTIVE INITIAL DESIGN OR MANUFACTURING. THUS PERFORMING TESTS OR VERIFICATION ON A DEVICE FROM THE SAME BATCH IS NOT RELEVANT.

    Description of Event or Problem · 1

    DATE OF INCIDENT: (B)(6) 2020. DESCRIPTION: THE TIP OF THE SCREWDRIVER BROKE WHILE SCREWING A LOCKING SCREW 3.5 (SP0135XX) DURING THE IMPLANTATION OF A LISFRANC PLATE. NO EXPLANTATION REQUIRED, BUT THE TIP COULD NOT BE REMOVED FROM THE PATIENT'S BODY, IT WAS MAINTAINED IN THE TORX FOOTPRINT. MORE DETAILS RECEIVED ON THE 12TH OF NOVEMBER 2020 : THE BREAKAGE HAPPENED "AT THE END OF SCREWING IN". THE TIP REMAINED "FLUSH IN THE SCREW". THE SURGERY WAS PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373284 AIRLOCK T8 AO SCREWDRIVER TIP SCREWDRIVER TIP HRS NOVASTEP AIRLOCK® T8 AO SCREWDRIVER TIP B00104 03700879500980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other