BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - RASP

    MDR report key: 2382099 · Received December 13, 2011

    Report

    Report Number
    9616680-2011-00799
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USING THE FEMORAL RASP DURING IMPACTING AND THEN REMOVING THE HEAD OF THE RASP SHEARED OFF AT THE JOIN OF THE BROACH. THE BROACH WAS DEEP SEATED AND MINIMAL STEM WAS OUTSIDE OF THE BONE - RETRIEVAL OF THE BROKEN RASP WAS DIFFICULT AND RESULTED IN A SLIGHT FRACTURE TO THE FEMUR, WHICH REQUIRED CABLING. THE SURGEON MANAGED TO GET AN OSTEOTOME UNDERNEATH THE RASP AND GENTLY HIT IT OUT. THIRTY MINUTES AND ADDITIONAL ANAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - RASP INSTRUMENT LXH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other