BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 12CM ANGLED ATTACHMENT

    MDR report key: 10749560 · Received October 28, 2020

    Report

    Report Number
    0001811755-2020-02960
    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
    07613327096576
    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 RATIONALECORRECTED DATA: H109 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.PRODUCT RETURN STATUS1 DEVICE WAS RECEIVED.8 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 CORRECTED DATA: B5, H10 11 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 2 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00104. - 9 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 7 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    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: 44 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 18 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00104. - 15 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00105. - 11 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 9 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. 2 DEVICES WERE NOT RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 9 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 9 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 11 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: 44 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 11 DEVICES WERE RECEIVED. 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 31 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 4 REPORTED EVENTS WERE CONFIRMED. 7 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS: 3 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 8 DEVICES WERE FOUND TO BE AFFECTED BY LUBRICATION BREAKDOWN. ADDITIONAL INFORMATION: 44 DEVICES WERE NOT LABELED FOR SINGLE-USE. 44 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 44 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 42 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209827 ELITE 12CM ANGLED ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO 5407-120-472 07613327096576

    Patients

    Seq Age Sex Outcome Treatment
    1