BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SYSTEM 7 RECIPROCATING SAW

    MDR report key: 8546258 · Received April 24, 2019

    Report

    Report Number
    0001811755-2019-01429
    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
    HWE
    UDI-DI
    07613327064834
    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 7 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER: - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2019-01401. - 6 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 6 DEVICES WERE RECEIVED.   EVENT CONFIRMATION STATUS 3 REPORTED EVENTS WERE CONFIRMED. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 3 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL COMPONENT CORROSION. 3 DEVICES HAD NO DEVICE PROBLEM FOUND.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

    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: 7 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 5 DEVICES WERE RECEIVED. 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 1 REPORTED EVENT WAS CONFIRMED; THE CAUSE TRACED TO COMPONENT FAILURE. 2 REPORTED EVENTS WERE NOT CONFIRMED. 2 DEVICE EVALUATIONS ARE STILL IN PROGRESS. EVALUATION RESULTS: 1 DEVICE WAS FOUND TO BE AFFECTED BY INTERNAL COMPONENT CORROSION 2 DEVICES HAD NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: 7 DEVICES WERE NOT LABELED FOR SINGLE-USE. 7 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 1 EVENT HAD NO INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340642 SYSTEM 7 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 07613327064834

    Patients

    Seq Age Sex Outcome Treatment
    1