BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SYSTEM 7 RECIPROCATING SAW

    MDR report key: 9244562 · Received October 28, 2019

    Report

    Report Number
    0001811755-2019-03372
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 30, 2019
    Report Date
    April 28, 2020
    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. CORRECTED DATA: H10. 11 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS. 7 DEVICES WERE RECEIVED. 4 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS. 3 REPORTED EVENTS WERE CONFIRMED. 4 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS. 2 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION/DEBRIS. 1 DEVICE WAS FOUND TO BE AFFECTED BY DRIVETRAIN WEAR. 3 DEVICES HAD NO PROBLEM FOUND. 1 DEVICE DID NOT HAVE A ROOT CAUSE ESTABLISHED.

    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: H10 7 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H10 11 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 4 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2019-03374. - 7 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 6 DEVICES WERE RECEIVED. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 3 REPORTED EVENTS WERE CONFIRMED. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 1 DEVICE WAS FOUND TO BE AFFECTED BY CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY A WORN DRIVETRAIN. 1 DEVICE WAS FOUND TO BE AFFECTED BY DEBRIS. 3 DEVICES HAD NO PROBLEM FOUND.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 11 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 7 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS 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: 11 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 11 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 11 DEVICES WERE NOT LABELED FOR SINGLE-USE. 11 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042479 SYSTEM 7 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 7206000000 07613327064834

    Patients

    Seq Age Sex Outcome Treatment
    1