BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 7CM STRAIGHT ATTACHMENT

    MDR report key: 12680102 · Received October 22, 2021

    Report

    Report Number
    3015967359-2021-02265
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 28, 2021
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HBE
    UDI-DI
    07613327096545
    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: 1 EVENT WAS PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT #3015967359-2021-02266. 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. H3 OTHER TEXT: NO EVENTS OCCURRED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE HAD PAINT CHIPS MISSING AND REPORTEDLY OVERHEATED.

    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: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD PAINT CHIPS MISSING AND REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583821 ELITE 7CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5407-120-450 07613327096545

    Patients

    Seq Age Sex Outcome Treatment
    1