BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DUAL TRIGGER WIRE COLLET

    MDR report key: 8284747 · Received January 29, 2019

    Report

    Report Number
    0001811755-2019-00269
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    December 25, 2018
    Report Date
    April 29, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    UDI-DI
    07613327304435
    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: 17 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 4 PREVIOUSLY REPORTED EVENTS IN THIS REPORT S WERE ALREADY REPORTED UNDER MFR REPORT # 0001811755-2018-02013. - 13 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 4 DEVICES WERE RECEIVED. 9 DEVICES WERE NOT AVAILABLE FOR EVALUATION. EVENT CONFIRMATION STATUS 1 REPORTED EVENTS WERE CONFIRMED; THE CAUSE WAS TRACED TO COMPONENT FAILURE. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 1 DEVICE WAS FOUND TO BE AFFECTED BY WORN AND DAMAGED COLLET ID AND FINGERS. ADDITIONAL INFORMATION 13 DEVICES WERE NOT LABELED FOR SINGLE-USE. 13 DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 13 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. 13 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: SEVENTEEN EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: SEVENTEEN DEVICES WERE RECEIVED. EVALUATION STATUS: NOT CONFIRMED; FOUR REPORTED EVENTS WERE NOT CONFIRMED DURING TESTING. IN PROGRESS; THIRTEEN DEVICE EVALUATIONS ARE IN PROGRESS. ADDITIONAL INFORMATION: SEVENTEEN DEVICES WERE NOT LABELED FOR SINGLE-USE. SEVENTEEN DEVICES WERE NOT REPROCESSED AND REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES SEVENTEEN MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. SEVENTEEN EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79857 DUAL TRIGGER WIRE COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 07613327304435

    Patients

    Seq Age Sex Outcome Treatment
    1