BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5MM ENTRY REAMER

    MDR report key: 9395915 · Received December 2, 2019

    Report

    Report Number
    1020279-2019-04222
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    February 20, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICES, INTENDED FOR TREATMENT, WERE RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED CHANNEL REAMER CONFIRMED THE STATED FAILURE MODE. A DOWEL PIN WAS DISLODGED, CAUSING THE REAMER TO SEPARATE. THE ENTRY REAMER SHOWED NICKS AND DEFORMATION TO THE FLUTES. THESE DEVICES WERE MANUFACTURED IN 2016 AND 2018. THE DEVICES EXHIBIT SIGNS OF MODERATE WEAR/ USAGE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LISTED BATCH DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBERS. THESE DEVICES ARE REUSABLE INSTRUMENTS THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. 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 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 DURING SURGERY AFTER REAMING WHILE REMOVING THE DEVICE WAS BROKEN; THE GRAY PART AND THE SILVER METAL PART SPLIT. NO HARM TO PATIENT. NO DELAY. NO BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194007 12.5MM ENTRY REAMER SYSTEM, ANALYSIS, ELECTRPHOETIC HEMOGLOBIN JBD SMITH & NEPHEW, INC. 16JM04782

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR