BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM

    MDR report key: 15073945 · Received July 21, 2022

    Report

    Report Number
    8030965-2022-05021
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    May 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    10886982181596
    PMA / PMN Number
    K082650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL PROCODE: LXT. 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

    DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE ICU OF THE HOSPITAL, WITH FOUR BROKEN SCHANZ SCREWS. THE PATIENT WAS ADMITTED IN A STATE OF COMPROMISED CONSCIOUSNESS, THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719837 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 294.57 10886982181596

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SCHANZSCR Ø5 L250/50 SST| SCHANZSCR Ø5 L250/50 SST| SCHANZSCR Ø5 L250/50 SST