BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER 44MM

    MDR report key: 4090582 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03472
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY REVIEW: THERE HAVE BEEN (B)(4) OTHER CONFIRMED EVENTS (INCLUDING THIS COMPLAINT) REPORTED FOR THE REPORTED MANUFACTURING LOT. THE RETURNED DEVICE WAS SHIPPED TO THE SUPPLIER FOR EVALUATION. THE SUPPLIER CONFIRMED THE EVENT. DULL REAMERS ARE A COMMON COMPLAINT WHICH OCCURS AS A RESULT OF THE PRODUCT EXCEEDING ITS EXPECTED USE. INSTRUCTIONS FOR USE (IFU) INSTRUCT CUSTOMERS TO DISCARD INSTRUMENTS WITH DULL CUTTING EDGES OR DAMAGES. MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE SPAN WHICH IS GENERALLY DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. THE RETURNED DEVICE WAS SHIPPED TO THE SUPPLIER, (B)(4), FOR EVALUATION. THE SUPPLIER CONFIRMED THE EVENT. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN ACETABULAR REAMERS SIZES 44-54. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ACETABULAR REAMERS 44-54 ARE DULL PER SURGEON.

    Description of Event or Problem · 1

    ACETABULAR REAMERS 44-54 ARE DULL PER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570470 ACETABULAR REAMER 44MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other