BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIS 16CM STRAIGHT ATTACHMENT

    MDR report key: 8546489 · Received April 24, 2019

    Report

    Report Number
    0001811755-2019-01491
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 26, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327096514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA:8 EVENTS WERE PREVIOUSLY REPORTED FOR THIS CATALOG NUMBER/DEVICE CODE COMBINATION DURING THE REPORTING PERIOD; HOWEVER, - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT #0001811755-2019-02229 - 7 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 7 DEVICES WERE RECEIVED.   EVENT CONFIRMATION STATUS 1 REPORTED EVENT WAS CONFIRMED. 6 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 2 DEVICES WERE FOUND TO BE AFFECTED BY BROKEN DOWN LUBRICATION. 5 DEVICES HAD NO DEVICE PROBLEM FOUND.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 7 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 8 EVENTS WERE REPORTED FOR THIS QUARTER.   PRODUCT RETURN STATUS: 2 DEVICES WERE RECEIVED. 6 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.   EVENT CONFIRMATION STATUS: 2 DEVICE EVALUATIONS ARE STILL IN PROGRESS.   ADDITIONAL INFORMATION: 8 DEVICES WERE NOT LABELED FOR SINGLE-USE. 8 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340708 MIS 16CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO 07613327096514

    Patients

    Seq Age Sex Outcome Treatment
    1