BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE

    MDR report key: 14074369 · Received April 11, 2022

    Report

    Report Number
    8030965-2022-02353
    Event Type
    Injury
    Date Received
    April 11, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    07611819195745
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: PATIENT HEIGHT REPORTED AS (B)(6). PATIENT¿S DATE OF BIRTH IS AN UNKNOWN DATE IN 1979. 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 · 0

    THE SITE (B)(6) REPORTED TWO ADVERSE EVENTS IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT MUE-010. POSTOPERATIVE ADVERSE EVENT: "SOFT TISSUE WOUND LOWER LEG; THE EPIGARD AND THE DERMOTRACTION STILL SECRETE BLOODY." IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES." IS THE AE RELATED TO THE DEVICE? "YES." DPS IMPLANT WAS USED. THIS REPORT IS FOR A 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

    Description of Event or Problem · 0

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THIS REPORT IS A DUPLICATE REPORT. EVENT WAS CAPTURED ON COMPLAINT (B)(4), MEDWATCH REPORT 8030965-2022-02111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901588 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES GMBH 07611819195745

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention UNK - SCREWS: NAIL LOCKING