BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HIP BONEC

    MDR report key: 2250800 · Received September 16, 2011

    Report

    Report Number
    1219602-2011-00152
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNUSED DEVICE WAS RETURNED. INNER BLADE DOES NOT SPIN FREELY WITHIN OUTER BLADE. THE INNER BLADE WAS OBSERVED TO HAVE SOME MINOR ROUNDING OVER OF THE EDGE FORM WHICH INDICATES CONTACT WITH THE OUTER EDGE FORM. THIS IS LIKELY THE SOURCE OF THE SHEDDING. THE INNER BLADE WAS EVALUATED FOR CONFORMANCE TO DIMENSIONAL REQUIREMENTS AND WAS FOUND TO CONFORM TO DESIGN. THE OUTER BLADE WAS OBSERVED TO HAVE A TOTAL INDICATED RUNOUT IN EXCESS OF DESIGN REQUIREMENT AND FURTHER MEASUREMENT OF THE OUTER BLADE INDICATED A .004 INCH BEND AT APPROXIMATELY THE MIDDLE OF THE BLADE. THIS BEND IN THE BLADE IS LIKELY RESPONSIBLE FOR THE MISALIGNMENT OF THE INNER BLADE IN RELATION TO THE OUTER BLADE AND RESULTED IN THE METAL TO METAL CONTACT WHICH LEAD TO THE SHEDDING. IT WAS DISCOVERED THAT THE ASSEMBLY OPERATORS WERE INCONSISTENT IN THE INSPECTION OF THE ASSEMBLED BLADE. HOWEVER, THIS PROBLEM WAS ADDRESSED AS A RESULT OF (B)(4) WITH A CHANGE TO ASSEMBLY PROCEDURES (B)(4) WHICH REQUIRES ASSEMBLY OPERATORS TO VERIFY THE BLADE ROTATION ON 100% OF ALL ASSEMBLIES BUILT, IDENTIFYING ANY FRICTION OR SEIZING OF BLADES AT ASSEMBLY. THE PROCESS IMPROVEMENT WAS IMPLEMENTED ON 1/14/11. DEVICE WAS MADE PRIOR TO THIS CHANGE TO THE PROCESS. (B)(4).

    Description of Event or Problem · 1

    METAL SHAVINGS - BLADE LEFT METAL SHAVING IN JOINT. ADDITIONAL INFORMATION CONFIRMED THAT SURGEON IRRIGATED AS MUCH OF THE SHEDDED MATERIAL OUT AS HE COULD BUT DID NOT REMOVE ALL OF IT, THE CASE CONTINUED WITH A BACK-UP DEVICE. ORIGINAL DEVICES ARE NOT BEING RETURNED, UNUSED DEVICES ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HIP BONEC BLADE,4.5 BONECUTTER,FR,180MM LG,DSP HAB SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7210979 50546412

    Patients

    Seq Age Sex Outcome Treatment
    1