BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER 51MM

    MDR report key: 3802792 · Received May 9, 2014

    Report

    Report Number
    0002249697-2014-01747
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WELD FRACTURE INVOLVING AN ACETABULAR REAMER WAS REPORTED. THE EVENT WAS CONFIRMED. -DEVICE EVALUATION AND RESULTS: EVALUATION PERFORMED BY THE SUPPLIER CONFIRMED THE EVENT. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: NO DISCREPANCIES WERE REPORTED. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE RETURNED DEVICE WAS SHIPPED TO THE SUPPLIER, (B)(4), FOR EVALUATION. THE SUPPLIER CONFIRMED THE EVENT AND INDICATED THE WELD FRACTURE WAS A RESULT OF WORN CUTTING TEETH. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THA SURGERY, THE ACETABULAR REAMER CAME APART DURING USE. DOCTOR MOVED TO THE NEXT REAMER AND NO DIFFICULTIES WERE EXPERIENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THA SURGERY THE ACETABULAR REAMER CAME APART DURING USE. DOCTOR MOVED TO THE NEXT REAMER AND NO DIFFICULTIES WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280523 ACETABULAR REAMER 51MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER ORTHOPAEDICS-MAHWAH V2011051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other