BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø4.5 SELF-TAP L38 SST

    MDR report key: 7404522 · Received April 6, 2018

    Report

    Report Number
    2939274-2018-51529
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982154682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE CORRECTED FROM (B)(6) 2018 - (B)(6) 2018. DEVICE 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K: K974537 KTT . DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: DHR REVIEW COULD NOT BE CONDUCTED DUE THE INSUFFICIENT INFORMATION¿S. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, 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. 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 (B)(6) 2018, FOR TREATMENT OF A PROXIMAL FEMUR FRACTURE. THE PATIENT WAS IMPLANTED WITH ONE (1) 130 DEGREE/62MM STANDARD BARREL 3 HOLE 62MM AND SCREWS. INTER-OPERATIVE, IT WAS REPORTED THAT A 4.5 CORTICAL SCREW BROKE DURING IMPLANTATION. THE ENTIRE HEAD OF THE SCREW BROKE OFF ALONG WITH 2MM OF THE SHAFT. THE SCREW SHAFT FRAGMENT WAS LEFT IN THE PATIENT BONE. IT WAS REPORTED THAT THE PATIENT HAD HARD BONE ON THE SPOT AND THE RESIDENT USED MORE FORCE THAN NECESSARY WHEN THE SCREW BROKE. ALL SCREW HOLE POSITION ON THE PLATE WAS FILLED. ANOTHER SCREW WAS AVAILABLE IN THE OPERATING ROOM. THIS NEW SCREW WAS IMPLANTED JUST BELOW THE SHAFT IN THE PLATE. THE BROKEN IMPLANT HAS BEEN RETAINED BY THE HOSPITAL. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THE PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICES: 130 DEGREE DHS® PLATE STANDARD BARREL 3 HOLES 62MM (ITEM # 281.031, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) UNKNOWN SCREWDRIVER (ITEM # UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) UNKNOWN SCREW (ITEM # UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN) THIS REPORT 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
    245465 CORTSCR Ø4.5 SELF-TAP L38 SST SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 214.838 10886982154682

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR