BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER RASP SIZE 0 37.5MM

    MDR report key: 4762783 · Received May 11, 2015

    Report

    Report Number
    0002249697-2015-01481
    Event Type
    Injury
    Date Received
    May 11, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 13, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING AN EXETER RASP WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS CONCLUDED NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO PATIENT INFORMATION WAS PROVIDED. -DEVICE HISTORY REVIEW: NO DISCREPANCIES WERE REPORTED. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 2 OTHER EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE DEVICE WAS CONFIRMED TO HAVE BROKEN FOLLOWING APPROXIMATELY 10 YEARS OF SERVICE. AN INSTRUMENT'S SERVICE LIFE IS FINITE AND DEPENDENT ON NUMBER OF USE CYCLES AND PROPER MAINTENANCE. A MATERIAL ANALYSIS CONCLUDED NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACES EXAMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6) HOSPITAL OPERATING THEATRES. SURGEON WAS IMPACTING EXETER RASP 37.5 SIZE 0 DOWN INTO THE PATIENT'S FEMUR WHEN THE NECK OF THE RASP SNAPPED OFF AT THE POINT WHERE THE BROACH CONNECTED. THIS LEFT THE RASP INSIDE THE PATIENT'S FEMUR WITH NO WAY OF ATTACHING THE BROACH HANDLE AGAIN IN ORDER TO REMOVE IT. REMOVAL REQUIRED THE CUTTING AWAY OF SOME EXTRA BONE IN ORDER TO EXPOSE MORE OF THE RASP. A VICE GRIP INSTRUMENT WAS THEN USED TO PULL THE BROKEN RASP FREE OF THE BONE.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6) PUBLIC HOSPITAL OPERATING THEATRES. SURGEON WAS IMPACTING EXETER RASP 37.5 SIZE 0 DOWN INTO THE PATIENT'S FEMUR WHEN THE NECK OF THE RASP SNAPPED OFF AT THE POINT WHERE THE BROACH CONNECTED. THIS LEFT THE RASP INSIDE THE PATIENT'S FEMUR WITH NO WAY OF ATTACHING THE BROACH HANDLE AGAIN IN ORDER TO REMOVE IT. REMOVAL REQUIRED THE CUTTING AWAY OF SOME EXTRA BONE IN ORDER TO EXPOSE MORE OF THE RASP. A VICE GRIP INSTRUMENT WAS THEN USED TO PULL THE BROKEN RASP FREE OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306736 EXETER RASP SIZE 0 37.5MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TDCE431

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other