BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROCHURE ASNIS III STRYKER ON DEMAND!

    MDR report key: 5520773 · Received March 23, 2016

    Report

    Report Number
    0008031020-2016-00147
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT BROCHURE ASNIS III STRYKER ON DEMAND! (REF# 982187) WAS ALLEGED OF ISSUE S-116 (LITERATURE DEVIATION / INFORMATION MISSING) COULD BE CONFIRMED WITH THE PROVIDED PHOTOGRAPHS. THEREFORE, A NON-CONFORMANCE HAS BEEN RAISED, SEE NC PR# 1127861 FOR FURTHER DETAILS. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT ON BROCHURE 982187 REV. 4 16/11 ON PAGE 20 REF 702611 SAYS THAT PRODUCT IS ASNIS III CANNULATED DRILL 6.5 MM WITH LARGE AO FITTING. CORRECT PRODUCT NUMBER IS 702601.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT ON BROCHURE 982187 REV. 4 16/11 ON PAGE 20 REF 702611 SAYS THAT PRODUCT IS ASNIS III CANNULATED DRILL 6.5 MM WITH LARGE AO FITTING. CORRECT PRODUCT NUMBER IS 702601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177148 BROCHURE ASNIS III STRYKER ON DEMAND! NA HWC STRYKER GMBH REV. 4 16/11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other