BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 7CM STRAIGHT ATTACHMENT

    MDR report key: 10749528 · Received October 28, 2020

    Report

    Report Number
    0001811755-2020-02967
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 30, 2020
    Report Date
    July 29, 2021
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    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 CORRECTED DATA: B5, H10 14 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 2 DEVICES WERE RECEIVED. 12 DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    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: 47 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 22 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00106. - 8 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00108. - 17 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 17 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.

    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: 17 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, 2 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00106. 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00108. 14 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 8 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 6 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 7 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 15 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 12 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

    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: 47 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 10 DEVICES WERE RECEIVED. 37 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 2 REPORTED EVENTS WERE CONFIRMED. 8 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS: 5 DEVICES WERE FOUND TO BE AFFECTED BY LUBRICATION BREAKDOWN. 5 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. ADDITIONAL INFORMATION: 47 DEVICES WERE NOT LABELED FOR SINGLE-USE. 47 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 47 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 45 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209900 ELITE 7CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO 5407-120-450 07613327096545

    Patients

    Seq Age Sex Outcome Treatment
    1