BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT BLADES

    MDR report key: 2498350 · Received March 21, 2012

    Report

    Report Number
    1219602-2012-00060
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THE RETURNED BLADE ASSEMBLY WAS EVALUATED FOR SHEDDING. THE INNER AND OUTER BLADE SUBASSEMBLIES WERE EVALUATED FOR DIMENSIONAL CONFORMANCE AND FOUND TO MEET DESIGN SPECIFICATION FOR TOTAL INDICATED RUNOUT OF THE TWO SUBASSEMBLIES. THE OUTER BLADE TIP AND TUBE ALIGNMENT WERE WITHIN SPECIFICATION. HOWEVER IT WAS OBSERVED THAT THERE WAS A SIGNIFICANT DEGREE OF SPLAY AT THE INNER BLADE EDGEFORM. THIS SPLAY IS TYPICALLY CAUSED BY THE STRESSES INDUCED IN THE BLADE TIP, DURING FORMING, AND RELEASED ONCE THE EDGEFORM IS CUT INTO THE TIP. THE SPLAY CAUSED A REDUCTION IN THE GAP BETWEEN THE INNER AND OUTER BLADE TIPS RESULTING IN FRICTION AND GALLING OF THE MATERIAL, LEADING TO SHEDDING. A CHANGE TO THE FABRICATION PROCESS FOR THE INNER BLADE HAS BEEN EFFECTED, VIA (B)(4), WHICH ELIMINATES THE SPLAY CONDITION. ADDITIONALLY, STEPS AT THE ASSEMBLY PROCESS HAVE BEEN INITIATED TO SCREEN FOR BLADE FRICTION PRIOR TO PACKAGING. (B)(4).

    Description of Event or Problem · 1

    METAL DEPOSITS FROM THE SHAVER BLADE WERE RELEASED INTO THE KNEE CAVITY. THE KNEE WAS WASHED OUT, BUT CERTAINLY METAL DEBRIS WOULD HAVE REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT BLADES BOXED TURBOTRIMMER BL,4.5 MM/6 HAB SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7205315 50613594

    Patients

    Seq Age Sex Outcome Treatment
    1