BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 18MM

    MDR report key: 8173619 · Received December 18, 2018

    Report

    Report Number
    2939274-2018-55438
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 26, 2018
    Report Date
    November 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982144751
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: DZL, KTW. DEVICE BROKE INTRA-OPERATIVELY; DEVICE IS NOT CONSIDERED IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4): THE SCREW BROKE DURING INSERTION. THE HEAD OF THE SCREW WAS REMOVED EASILY, HOWEVER ADDITIONAL INSTRUMENTATION WAS USED TO REMOVE THE SHAFT FROM THE BONE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIA SHAFT SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, A CORTEX SCREW HEAD BROKE OFF DURING FINAL TIGHTENING DUE TO PATIENTS HARD BONE. BROKEN FRAGMENTS WERE REMOVED USING A SCREW REMOVAL SET ON THE SCREW SHAFT WITH TREPHINE AND A CONICAL REMOVAL TOOLS. A LOCKING COMPRESSION DYNAMIC COMPRESSION PLATE WAS SELECTED AS PROVISION FIXATION PRIOR TO INTRAMEDULLARY NAILING. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS AS PLANNED. CONCOMITANT DEVICE REPORTED: LOCKING COMPRESSION DYNAMIC COMPRESSION PLATE (PART # 242.206, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014337 2.7MM CORTEX SCREW SELF-TAPPING 18MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 202.818 10886982144751

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention