BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CORE, MAESTRO DRILL

    MDR report key: 8546234 · Received April 24, 2019

    Report

    Report Number
    0001811755-2019-01406
    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
    HBB
    UDI-DI
    04546540469113
    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 32 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2019-01404. - 31 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 31 DEVICES WERE RECEIVED. EVENT CONFIRMATION STATUS 27 REPORTED EVENTS WERE CONFIRMED. 4 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 25 DEVICES WERE FOUND TO BE AFFECTED BY A HOLE IN THE HOSE. 1 DEVICE WAS FOUND TO BE AFFECTED BY NON-STRYKER REPAIR. 1 DEVICE WAS FOUND TO BE AFFECTED BY MECHANICAL DAMAGE. 4 DEVICES HAD NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION 31 DEVICES WERE NOT LABELED FOR SINGLE-USE. 31 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 31 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE EXHAUST HOSE, WHICH PASSES AIR AND LUBRICANT, WAS FOUND TO HAVE A HOLE IN IT. 29 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 1 EVENT HAD 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: 32 EVENTS WERE REPORTED FOR THIS QUARTER.   PRODUCT RETURN STATUS: 31 DEVICES WERE RECEIVED. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED.   EVENT CONFIRMATION STATUS: 7 REPORTED EVENTS WERE CONFIRMED; THE CAUSE TRACED TO COMPONENT FAILURE. 1 REPORTED EVENT WAS NOT CONFIRMED. 23 DEVICE EVALUATIONS ARE STILL IN PROGRESS. EVALUATION RESULTS: 6 DEVICES WERE FOUND TO BE AFFECTED BY A HOLE IN THE HOSE. 1 DEVICE WAS FOUND TO BE AFFECTED BY A LOOSE COMPONENT. 1 DEVICE HAD NO DEVICE PROBLEM FOUND.   ADDITIONAL INFORMATION: 32 DEVICES WERE NOT LABELED FOR SINGLE-USE. 32 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 32 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE EXHAUST HOSE, WHICH PASSES AIR AND LUBRICANT, WAS FOUND TO HAVE A HOLE IN IT. 30 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340555 CORE, MAESTRO DRILL MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 04546540469113

    Patients

    Seq Age Sex Outcome Treatment
    1