BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEG-WAY ECUTR

    MDR report key: 15629523 · Received October 18, 2022

    Report

    Report Number
    3010760216-2022-00001
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    January 8, 2017
    Report Date
    October 18, 2022
    Manufacturer
    TRICE MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA#S-P#NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON A MEDWATCH INCIDENT REPORT FORWARDED TO US FROM THE FDA. THE INITIAL REPORTER TO THE FDA WAS A PHYSICIAN / SURGEON BUT DID NOT PROVIDE THEIR NAME IN THE REPORT. WE WERE NOT ABLE TO CONTACT THEM FOR POSSIBLE ADDITIONAL INFORMATION. THE PHYSICIAN DID REPORT THAT IT WAS AN ADVERSE EVENT WITHOUT AN IDENTIFIED DEVICE OR USE PROBLEM. TRICE MEDICAL, INC. ACQUIRED SEGWAY ORTHOPAEDICS IN FEBRUARY 2019. THE REPORTED INCIDENT OCCURRED (B)(6) 2017, PRIOR TO THE ACQUISITION. WE WERE NOT ABLE TO IDENTIFY THE COMPLAINT OR INVESTIGATION RECORD FROM SEGWAY FOR THIS INCIDENT. WE WERE ALSO NOT ABLE TO LOCATE THE DEVICE THAT WAS REPORTED TO BE RETURNED TO SEGWAY. THE COMPLETE DEVICE PART NUMBER WAS NOT REPORTED. THE REPORTED PART NUMBER IDENTIFIED THE GENERAL MODEL OF THE INSTRUMENT SET, BUT NOT THE SPECIFIC INSTRUMENT SET CONFIGURATION. A PART NUMBER FOR A SPECIFIC INSTRUMENT SET WAS ENTERED AS 200-5560-UCU ON THIS FORM 3500A BASED ON THE PROCEDURE REPORTED (CUBITAL TUNNEL RELEASE). IT IS POSSIBLE THAT A DIFFERENT INSTRUMENT SET CONFIGURATION WAS USED.

    Description of Event or Problem · 0

    WE RECEIVED A PHYSICIAN REPORT OF AN INCIDENT THROUGH THE MEDWATCH PROGRAM. THE PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED A NERVE INJURY DURING A CUBITAL TUNNEL RELEASE PROCEDURE WITH A SEG-WAY INSTRUMENT SET. IT WAS REPORTED THAT THE INJURY WAS CAUSED BY "TRACTION BY THE DEVICE" DURING USE AND RESULTED IN SOME SENSORY LOSS AND ULNAR INTRINSIC ATROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176743 SEG-WAY ECUTR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH TRICE MEDICAL, INC. 200-5560 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability