BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II XR TIB ORIENTN STYLUS RT

    MDR report key: 15656567 · Received October 23, 2022

    Report

    Report Number
    1020279-2022-04522
    Event Type
    Malfunction
    Date Received
    October 23, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 23, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTZ
    UDI-DI
    00885556238141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3, H6: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION CONFIRMED THAT THE DEVICE WAS MISSING ITS SHOULDER BOLT COMPONENT RENDERING THE DEVICE INOPERABLE. THE DEVICE ALSO SHOWS SIGNS OF EXTENSIVE USE AND WEAR. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. A CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED AS THE DEVICE WAS MISSING A COMPONENT. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. B5: DESCRIBE EVENT OR PROBLEM, H6: MEDICAL DEVICE PROBLEM CODE AND H8: USAGE OF DEVICE.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JRNY II XR TIB ORIENTN STYLUS RT WAS MISSING ITS SHOULDER BOLT COMPONENT RENDERING THE DEVICE INOPERABLE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JRNY II XR TIB ORIENTN STYLUS RT WAS BROKEN IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003452 JRNY II XR TIB ORIENTN STYLUS RT CALIPER KTZ SMITH & NEPHEW, INC. 74014466 17GBG0019 00885556238141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown