BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 12CM STRAIGHT ATTACHMENT

    MDR report key: 18519836 · Received January 16, 2024

    Report

    Report Number
    3015967359-2024-00081
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 31, 2023
    Report Date
    January 22, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HBE
    UDI-DI
    07613327096569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: B5, H6, H10 74 EVENTS WERE ORIGINALLY REPORTED FOR THIS FAILURE MODE DURING THE REPORTING QUARTER; HOWEVER, - 2 EVENTS WERE INADVERTENTLY EXCLUDED. - 76 REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 76 DEVICES WERE EVALUATED IN THE FIELD. ADDITIONAL INFORMATION 76 DEVICES WERE NOT LABELED FOR SINGLE-USE. 76 DEVICES WERE NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 74 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 74 DEVICES WERE EVALUATED IN THE FIELD. ADDITIONAL INFORMATION 74 DEVICES WERE NOT LABELED FOR SINGLE-USE. 74 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 76 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 76 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 74 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 74 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713646 ELITE 12CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327096569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown