BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MICRODRILL SERIES STRAIGHT ATTACHMENT

    MDR report key: 7714801 · Received July 24, 2018

    Report

    Report Number
    0001811755-2018-01220
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    March 2, 2018
    Report Date
    March 14, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    UDI-DI
    04546540380272
    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: TEN EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: NINE DEVICES WERE RECEIVED FOR EVALUATION. ONE DEVICES WERE AVAILABLE FOR EVALUATION BUT HAVE NOT YET BEEN RECEIVED. EVALUATION STATUS: FOUR EVENTS WERE CONFIRMED DURING TESTING -FOUR DEVICES WERE FOUND TO BE AFFECTED BY DETACHED OR MISSING PIECES. FIVE DEVICE EVALUATIONS ARE IN PROGRESS. PRODUCT DISPOSITION: THESE DEVICES ARE NOT REPAIRABLE AND WERE NOT RETURNED TO THE USER FACILITY. ADDITIONAL INFORMATION: THERE WERE NO REMEDIAL ACTIONS TAKEN ON THIS DEVICE. THIS DEVICE IS NOT LABELED FOR SINGLE-USE.

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2015055.   SUPPLEMENTAL RATIONALE CORRECTED DATA: 10 EVENTS WERE INITIALLY REPORTED. 10 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.   PRODUCT RETURN STATUS 9 DEVICES WERE RECEIVED. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION.   EVALUATION STATUS 8 REPORTED EVENTS WERE CONFIRMED DURING TESTING. - 2 DEVICES WERE FOUND TO BE AFFECTED BY A MISSING COMPRESSION SPRING AND COUPLER COMPONENTS. - 1 DEVICE WAS FOUND TO BE AFFECTED BY A MISSING COUPLER PIN, COUPLER COVER AND COMPRESSION SPRING. - 4 DEVICES WERE FOUND TO BE AFFECTED BY THE NOSE CONE SEPARATED FROM THE HOUSING. - 1 DEVICE WAS FOUND TO BE AFFECTED BY A MISSING COUPLER PIN. 1 REPORTED EVENT WAS NOT CONFIRMED DURING TESTING. ADDITIONAL INFORMATION 10 DEVICES WERE NOT LABELED FOR SINGLE-USE. 10 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: 6 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.   PRODUCT RETURN STATUS 1 DEVICE WAS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED.   EVALUATION STATUS 2 REPORTED EVENTS WERE CONFIRMED DURING TESTING. -  2 DEVICES WERE FOUND TO BE AFFECTED BY DETACHED COUPLER COMPONENT(S) AND COMPRESSION SPRING. 3 DEVICE EVALUATIONS ARE IN PROGRESS. ADDITIONAL INFORMATION 6 DEVICES WERE NOT LABELED FOR SINGLE-USE. 6 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. TEN EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 10 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 10 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558652 MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO E2015055 04546540380272

    Patients

    Seq Age Sex Outcome Treatment
    1