BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXIS T25-S 1/4" SCREWDRIVER TIP

    MDR report key: 10257363 · Received July 10, 2020

    Report

    Report Number
    3010673777-2020-00001
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 9, 2020
    Manufacturer
    NOVASTEP
    Product Code
    HWE
    UDI-DI
    03700879509761
    PMA / PMN Number
    K143229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS PERFORMED ON THE BREAKING AREA AND ITS SHAPE SUGGEST THAT THE TIP WAS INSERTED IN A DEPTH OF 2MM IN THE SCREW, ALTHOUGH THE THEORETICAL MAX DEPTH IS 3.2MM. A CONTROL HAS BEEN PERFORMED ON 3 SCREWDRIVERS OF THE SAME BATCH IN ASSOCIATION WITH THE REFERENCE SCREW USED FOR THE CONTROL AT ARRIVAL. THE DEPTH OF INSERTION WAS BETWEEN 2.87 AND 2.96 MM. THESE ELEMENTS DO NOT SUPPORT THE THEORY TELLING THAT THE INSUFFICIENT INSERTION WOULD BE DUE TO A DEFECT OF THE IMPLIED DEVICE. THE SCREW BEING IMPLANTED WHEN THE INCIDENT OCCURRED HAS BEEN IDENTIFIED. THE DHR DO NOT MENTION ANY NON-CONFORMITY IN REGARD TO SPECIFICATIONS. THIS SUGGESTS THAT THE POTENTIAL INSUFFICIENT INSERTION WOULDN'T NEITHER BE DUE TO A DEFECT OF THE SCREW. PATIENT STATEMENT : CURRENT PATIENT'S STATE OF HEALTH: NO PAIN, EXCELLENT CONSOLIDATION - NO NEED TO REMOVE THE IMPLANT. MDR CLOSED.

    Description of Event or Problem · 0

    SURGERY OF (B)(6) 2020, (B)(6). " INSTRUMENT BREAKAGE: OCCURRED AT THE END OF THE INTERVENTION WHEN THE SURGEON TRIED TO INSERT A SCREW HEAD IN A CORTEX. THE SURGERY WAS CARRIED OUT CORRECTLY EXCEPT FOR THE IMPLANTATION OF THE 3RD SCREW. THIS SCREW HAS NOT BEEN INSERTED ENOUGH, WHICH CAN ANNOY THE PATIENT. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE SCREW BUT IT WAS NOT POSSIBLE. A FOLLOW-UP IS DONE TO ENSURE THAT THE FULL ARTHRODESIS IS DONE. IN CASE OF THE THIRD SCREW HEAD IS TOO ANNOYING, A NEW SURGERY WILL BE PLANNED FOR REMOVAL OF IT. CUSTOMER COMPLAINT : (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIPTION : NEXIS T25-S 1/4" SCREWDRIVER TIP - VERSION A. BATCH NUMBER : F00037. LOT OF XSD06003. ANALYSIS OF THE BATCH : 154 PARTS. STATE OF THE STOCK ON (B)(6) 2020: ALL PARTS HAVE BEEN PUT ON THE MARKET EXCEPT ONLY ONE STILL IN STOCK. NO BREAKAGE DEFECT ON THE OTHER PARTS OF THIS BATCH. CUSTOMER COMPLAINT : (B)(4). INVESTIGATION : WE HAVE CONDUCTED A BATCH FILE CHECK, AN ANALYSIS OF THE MATERIAL CERTIFICATE (CHEMICAL COMPOSITION, HARDNESS) AND CHECKED THE DIMENSIONAL CHARACTERISTICS OF THE RECEIVED PIECE. THE ANALYSES DID NOT SHOW ANY DISCREPANCY COMPARED TO THE MANUFACTURING SPECIFICATIONS THAT COULD GENERATE A PARTICULAR BREAKAGE RISK.

    Description of Event or Problem · 1

    SURGERY OF (B)(6) 2020, (B)(6). " INSTRUMENT BREAKAGE: OCCURRED AT THE END OF THE INTERVENTION WHEN THE SURGEON TRIED TO INSERT A SCREW HEAD IN A CORTEX. THE SURGERY WAS CARRIED OUT CORRECTLY EXCEPT FOR THE IMPLANTATION OF THE 3RD SCREW. THIS SCREW HAS NOT BEEN INSERTED ENOUGH, WHICH CAN ANNOY THE PATIENT. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE SCREW BUT IT WAS NOT POSSIBLE. A FOLLOW-UP IS DONE TO ENSURE THAT THE FULL ARTHRODESIS IS DONE. IN CASE OF THE THIRD SCREW HEAD IS TOO ANNOYING, A NEW SURGERY WILL BE PLANNED FOR REMOVAL OF IT. CUSTOMER COMPLAINT : (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723670 NEXIS T25-S 1/4" SCREWDRIVER TIP SCREWDRIVER TIP HWE NOVASTEP NEXIS T25-S 1/4" SCREWDRIVER TIP F00037 03700879509761

    Patients

    Seq Age Sex Outcome Treatment
    1 Other