BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE

    MDR report key: 11579149 · Received March 27, 2021

    Report

    Report Number
    2939274-2021-01549
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    February 27, 2021
    Report Date
    February 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982272232
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. 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 ON (B)(6) 2021, DURING FEMORAL RECON NAIL (FRN) INSERTION, THE FRN NAIL BECAME STUCK IN THE CANAL REQUIRING FORCEFUL IMPACTION AND SUBSEQUENT EXTRACTION. THE DRIVING CAP/THREADED BROKE OFF. DURING THE EXTRACTION OF THE FRN NAIL, THE TWO (2) UNIVERSAL CHUCK WITH T-HANDLE BROKE DUE TO FORCEFUL EXTRACTION. ACTION TAKEN WHEN THE EVENT OCCURRED WAS EXTRACTION OF NAIL, NEW REAM ROD INSERTED AND SAME FRN NAIL WAS INSERTED INTO FEMUR. THERE WAS SIXTY (60) MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476296 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.033.968S 10886982272232

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR