BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL RADIUS BLADE

    MDR report key: 1980763 · Received February 7, 2011

    Report

    Report Number
    1219602-2010-00245
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    August 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE WAS, UNDER MAGNIFICATION, TO EXHIBIT A GALLED BAND OF MATERIAL AROUND THE CIRCUMFERENCE OF THE BLADE, JUST BELOW THE EDGEFORM. THE EDGEFORM ITSELF WAS INTACT AND IN GOOD CONDITION. THE INNER BLADE CONFORMED TO DESIGN REQUIREMENT FOR STRAIGHTNESS. THE OUTER BLADE WAS EXAMINED FOR STRAIGHTNESS AND TIR AND FOUND TO BE BENT .026 INCHES FROM DEAD STRAIGHT. FURTHER EXAMINATION REVEALED THAT THE ADAPTER BODY, MOLDED TO THE OUTER TUBE, EXHIBITED TWO AXIAL FRACTURES. THE BLADE EXPERIENCED EXCESSIVE LATERAL LOAD WHICH CRACKED THE ADAPTER BODY CAUSING A MISALIGNMENT OF THE OUTER BLADE IN RELATION TO THE INNER BLADE, CAUSING FRICTION BETWEEN THE TWO BLADES. ROOT CAUSE OF INVESTIGATION: EXCESSIVE FORCE WAS USED. (B)(4)

    Description of Event or Problem · 1

    METAL SHAVINGS FROM THE SHAVER BLADE. SURGEON USED DYONICS PUMP TO TRY FLUSH OUT. HE PUT THE SHAVER BACK IN TO SUCK THE METAL SHAVINGS UP TO FIND THAT MORE METAL SHAVINGS CAME OUT. THERE ARE SHAVINGS LEFT IN THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL RADIUS BLADE FULL RADIUS BLADE,5.5MM DSPL. EP-1 HAB SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7205307 50510328

    Patients

    Seq Age Sex Outcome Treatment
    1