BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE

    MDR report key: 12641953 · Received October 15, 2021

    Report

    Report Number
    2939274-2021-06131
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271815
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT, PART: 04.033.270S-US, LOT: L984217, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 13 AUGUST 2018, EXPIRATION DATE: 31 JULY 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE ATTEMPTING TO INSERT RECON SCREWS INTO AN UNKNOWN FEMORAL RECON NAIL (FRN), THE SURGEON HIT THE NAIL WITH THE DRILL BIT. THE NAIL WAS UNSTABLE BECAUSE THE SURGEON DID NOT PIN BOTH TROCARS BEFORE REMOVING GUIDE WIRE TO DRILL THE FIRST HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE. THIS REPORT IS 1 OF 10 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535578 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.033.270S L984217 10886982271815

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR