BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 14CM STRAIGHT ATTACHMENT

    MDR report key: 8014389 · Received October 29, 2018

    Report

    Report Number
    0001811755-2018-01960
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    June 2, 2018
    Report Date
    January 31, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327096583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2015055. REPORTED EVENTS: 80 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 79 DEVICES WERE RECEIVED FOR EVALUATION. 1 DEVICE WAS NOT AVAILABLE TO STRYKER FOR EVALUATION. EVALUATION STATUS: 78 EVENTS WERE CONFIRMED DURING TESTING. 78 DEVICES WERE FOUND TO BE AFFECTED BY MISSING PAINT CHIPS. 1 DEVICE EVALUATION IS IN PROGRESS. ADDITIONAL INFORMATION: 80 DEVICES WERE NOT LABELED FOR SINGLE-USE. 80 DEVICES WERE NOT REPROCESSED AND REUSED.

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2015055. SUPPLEMENTAL RATIONALE CORRECTED DATA: 80 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER: - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2018-02213. - 79 TOTAL EVENTS WERE REPORTED FOR THIS CATALOG NUMBER/DEVICE CODE COMBINATION FOR THE REPORTING QUARTER.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 80 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 80 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 79 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 79 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856036 ELITE 14CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO 07613327096583

    Patients

    Seq Age Sex Outcome Treatment
    1