BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 7403788 · Received April 6, 2018

    Report

    Report Number
    2939274-2018-51510
    Event Type
    Injury
    Date Received
    April 6, 2018
    Report Date
    March 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982154644
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DOB & WEIGHT NOT PROVIDED FOR REPORTING. DATE UNKNOWN WHEN DEVICE MALFUNCTIONED. COMPLAINANT PART WAS RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION ADDITIONAL INFO: K974537 KTT PATIENT CODE USED FOR: THE PATIENT EXPERIENCED NONUNION AND A BROKEN SCREW REQUIRING REVISION SURGERY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW COULD NOT BE CONDUCTED DUE THE INSUFFICIENT INFORMATION¿S. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: KTT. PART OF THE SCREW REMAINED IN THE PATIENT¿S BONE; DEVICE NOT CONSIDERED EXPLANTED. DATE DEVICE RECEIVED TO MANUFACTURER IS REPORTED INADVERTENTLY ON THE INITIAL MEDWATCH. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION; AS SUCH DEVICE RECEIVED DATE IS NOT APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON UNKNOWN DATE FOR TREATMENT OF A HUMERAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 4.5MM NARROW (LCP)LOCKING COMPRESSION 9 HOLE/170MM PLATE AND FOUR (4) 4.5MM CORTEX SELF TAPPING 30MM SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, PATIENT PRESENTED WITH A NON-UNION. ON (B)(6) 2018, SURGEON REMOVED IMPLANTS AND REVISED THE PATIENT TO 8-HOLE PLATE AND SCREWS. AT THE BEGINNING OF THE PROCEDURE, ONE (1) OF THE 4.5MM SCREWS WAS REPORTED AS BROKEN. THE DISTAL SHAFT PORTION OF THIS 4.5MM CORTEX SCREW WAS LEFT IN THE PATIENT¿S HUMERAL BONE. SURGEON CHOSE NOT TO RETRIEVE THE BROKEN SCREW SHAFT PORTION. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5-10-MINUTE TIME DELAY DUE TO THE BROKEN SHAFT TIP. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICE REPORT: [UNKNOWN STRYKER HAND DRILL] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). (B)(4) IS FOR 4.5MM CORTEX SCREW BREAKING POST-IMPLANT AND (B)(4) WAS OPENED FOR THE TIP OF THE RIA BREAKING INTRAOPERATIVELY. THIS COMPLAINT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246549 4.5MM CORTEX SCREW SELF-TAPPING 30MM SCREW, FIXATION. BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 214.830 10886982154644

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention