BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER CENTROLOCK T7

    MDR report key: 10836893 · Received November 13, 2020

    Report

    Report Number
    3010673777-2020-00003
    Event Type
    Injury
    Date Received
    November 13, 2020
    Report Date
    November 12, 2020
    Manufacturer
    NOVASTEP
    Product Code
    HWE
    UDI-DI
    03700879511740
    PMA / PMN Number
    K192356
    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 SURGERY: DEVICE DID NOT APPEAR DEFECTIVE; CIRCUMSTANCES : INTRAOPERATIVELY PLACING 2.5 LOCKING SCREW INTO THE METATARSAL CAPITAL FRAGMENT. SURGEON: PART OF THE DESIGN TEAM. NO PATIENT DATA AVAILABLE. DESCRIPTION OF THE PRODUCT : THE MEDICAL DEVICE INVOLVED IN THIS COMPLAINT IS THE SCREWDRIVER CENTROLOCK T7, REF. (B)(4). IT'S A NON-CANNULATED SCREWDRIVER WITH A CLASSICAL TORX T7 TIP. TRAÇABILITÉ OF THE DEVICE: NOT COMMUNICATED FOR THE MOMENT. CHECK OF DHR : TRACEABILITY OF THE BROKEN PART HAS NOT BEEN COMMUNICATED FOR THE MOMENT. EN ATTENTE DE N° DE LOT EMBOUT: REVIEW OF HISTORICAL OF NC AND COMPLAINT : FIRST OCCURRENCE OF SUCH A DEFECT. ANALYSIS OF THE BROKEN PRODUCT : NOT RETURNED TO US CONCLUSION: WITHOUT TRACEABILITY OF THE DEVICE AND NO RETURN OF THE BROKEN PART, NO CONCLUSION FOR THE MOMENT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED ON 2020/10/19: "BROKEN DRIVER WHILE INSERTING A CENTROLOCK SCREW LAST WEEK." SCREW DRIVER TIP SHEERED OFF WHILST PLACING A 2.5 LOCKING SCREW. THE TIP WAS LEFT IN THE HEAD OF THE SCREW AND COULD NOT BE RETRIEVED. ADDITIONAL DATA ON 2020/10/20: THE BROKEN DRIVER TIP WAS FLUSH WITH THE SCREW, THEREFORE WAS NOT ABLE TO REMOVE THE DEBRIS & REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299449 SCREWDRIVER CENTROLOCK T7 SCREWDRIVER HWE NOVASTEP SCREWDRIVER CENTROLOCK T7 UNKNOW 03700879511740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other