BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULER

    MDR report key: 11056838 · Received December 22, 2020

    Report

    Report Number
    1020279-2020-07701
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 23, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FTZ
    UDI-DI
    03596010560759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE TOP OF THE DEVICE IS DAMAGED RENDERING IT INOPERABLE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF 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 FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP COLLAR OF THE RULER IS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518150 RULER TAPE, MEASURING, RULERS AND CALIPERS FTZ SMITH & NEPHEW, INC. 71674079 UNKNOWN 03596010560759

    Patients

    Seq Age Sex Outcome Treatment
    1