BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE

    MDR report key: 2964586 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00705
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. MATERIAL ANALYSIS: A MATERIAL ANALYSIS WAS PERFORMED CONCLUDING: THE LATCH LEVER OF THE LEFT NAV COMPATIBLE DUAL OFFSET ACCOLADE RASP HANDLE BROKE FATIGUE. EDS ANALYSIS SHOWED THE LATCH LEVER OF THE LEFT NAV COMPATIBLE DUAL OFFSET ACCOLADE RASP HANDLE TO BE MADE OF (B)(4) CONSISTENT WITH A 300 SERIES STAINLESS STEEL ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACES EXAMINED. THE DEVICE WAS DETERMINED TO BE WITHIN THE SCOPE OF NCR, WHICH WAS INITIATED DUE TO AN INCONSISTENCY BETWEEN HARDNESS CALLOUTS ON THE LATCH LEVER COMPONENT DRAWINGS AND THE MEASURED HARDNESS OF THE PARTS, WHICH WERE IN AGREEMENT WITH THE MATERIAL SPECIFICATION. ECN WAS RAISED TO REMOVE THE HARDNESS REQUIREMENT ON THE DRAWING, WHICH IS NOW CONTROLLED BY THE MATERIAL SPECIFICATION, AND TO CHANGE THE BLEND RADIUS AND WIDTH TO DECREASE THE MAX PRINCIPAL STRESSES ON THE AFFECTED AREAS OF THE LEVER ARM. ADDITIONALLY, THERE WAS SEVERE IMPACTION MARKS ON AND AROUND THE LEVER ARM, INDICATING IT WAS STRUCK WITH A MALLET TO RELEASE THE HANDLE REPEATEDLY. THE HANDLE IS TO BE IMPACTED ON THE STRIKE PLATE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED.

    Description of Event or Problem · 1

    DR. (B)(6) WAS BROACHING WITH A DIRECT ANTERIOR BROACH HANDLE WHEN HE WENT TO EXCHANGE THE BROACH THE LATCH BROKE ON THE HANDLE. I IMMEDIATELY REPLACED THE HANDLE FROM ANOTHER SET WITH NO PATIENT IMPLICATION OR ADVERSE EVENT. DR. (B)(6) COMPLETED THE HIP SURGERY IN USUAL FASHION.

    Description of Event or Problem · 1

    DR. (B)(6) WAS BROACHING WITH A DIRECT ANTERIOR BROACH HANDLE WHEN HE WENT TO EXCHANGE THE BROACH THE LATCH BROKE ON THE HANDLE. I IMMEDIATELY REPLACED THE HANDLE FROM ANOTHER SET WITH NO PATIENT IMPLICATION OR ADVERSE EVENT. DR. (B)(6) COMPLETED THE HIP SURGERY IN USUAL FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66468 LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P4H115

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other