BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOXED INCISOR PLUS BL,(BX6)

    MDR report key: 4945243 · Received July 28, 2015

    Report

    Report Number
    1219602-2015-00524
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    February 10, 2015
    Report Date
    July 27, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 4.5 RADIUS INCISOR BLADE WAS RETURNED FOR EVALUATION. THE INNER BLADE WAS REMOVED FROM THE OUTER SHEATH. THE DEVICE WAS VISUALLY EVALUATED AND IDENTIFIED TO HAVE SIGNIFICANT SCORING ALONG THE SHAFT OF THE DEVICE. SEE ATTACHED PICTURES. THE DEVICE WAS DIMENSIONALLY EVALUATED AND MEETS SPECIFICATION. A REVIEW OF THE NONCONFORMANCE DATABASE DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURE OF THE LOT. A REVIEW OF THE PROVIDED CASE DETAILS DID NOT INCLUDE ANY INFORMATION THAT CAN CONTRIBUTE TO THE DEVICE INVESTIGATION. PER THE DEVICE IFU ¿EXCESSIVE ¿SIDE-LOADING¿ ON THE BLADE DURING USE DOES NOT IMPROVE CUTTING PERFORMANCE AND IN EXTREME CASES MAY RESULT IN WEAR AND DEGRADATION OF THE INNER ASSEMBLY.¿ THE FAILURE MODE IS CONFIRMED, THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR. NO ADDITIONAL ACTION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THE COMPANY WILL CONTINUE TO ANALYZE ADDITIONAL COMPLAINTS AS THEY ARE REPORTED. (B)(4).

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC KNEE DEBRIDEMENT, THE SURGEON WAS SHAVING SOME OF THE FAT PAD FROM THE DESIGNATED AREAS AND HE NOTICED SMALL METAL FRAGMENTS WERE FALLING IN THE KNEE JOINT. THE SURGEON SUSPECTED THE METAL DEBRIS WAS COMING FROM THE SHAVER TIP. AT THE END OF THE PROCEDURE, THE SURGEON USED A METAL SUCKER TO REMOVE ALL THE METAL FRAGMENTS. NO RESIDUAL METAL FRAGMENTS WERE LEFT IN THE KNEE JOINT. THE CASE WAS NOT DELAYED AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489895 BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50827411

    Patients

    Seq Age Sex Outcome Treatment
    1