BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER RASP SIZE 0 37.5/44MM

    MDR report key: 3032095 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01174
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 NO OTHER EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE DEVICE WAS CONFIRMED TO HAVE BROKEN FOLLOWING 9 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.

    Description of Event or Problem · 1

    UPON IMPACTING THE 40MM #0 EXETER RASP INTEROPERATIVELY THE TIP OF THE BROACH BROKE OFF AT THE NARROW PART OF THE CUT OUT 'V'.

    Description of Event or Problem · 1

    UPON IMPACTING THE 40MM #0 EXETER RASP INTEROPERATIVELY THE TIP OF THE BROACH BROKE OFF AT THE NARROW PART OF THE CUT OUT 'V'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136571 EXETER RASP SIZE 0 37.5/44MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TDCE300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other