BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 6980312 · Received October 26, 2017

    Report

    Report Number
    0001811755-2017-01981
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 1, 2017
    Report Date
    January 29, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION E2013007. THREE EVENTS WERE REPORTED FOR THIS QUARTER. TWO DEVICES WERE NOT AVAILABLE FOR EVALUATION. ONE DEVICE EVALUATION IS IN PROGRESS. THERE WERE NO REMEDIAL ACTIONS TAKEN. THESE DEVICES ARE LABELLED FOR SINGLE-USE. TWO DEVICES NOT RETURNED, ONE DEVICE AWAITING EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2013007. DEVICE PRODUCT CODE: CORRECTED TO GFA. THE DEVICE IDS IN THIS REPORT WERE CITED AS HWE. HWE DOES NOT CORRELATE WITH THE PRODUCT CODE GFA IN THE ORIGINAL ACCEPTANCE LETTER. THE PRODUCT CODE FOR THESE DEVICES WERE RETURNED TO GFA TO ALIGN TO THE PRODUCT CODE IN THE ORIGINAL ACCEPTANCE LETTER AND REPORTED UNDER REPORT NUMBER 0001811755-2017-01979.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICES BROKE DURING A SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICES BROKE DURING A SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758351 UNKNOWN_INSTRUMENTSTIRE_PRODUCT BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1