BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 12CM STRAIGHT ATTACHMENT

    MDR report key: 11215313 · Received January 22, 2021

    Report

    Report Number
    0001811755-2021-00223
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    December 31, 2020
    Report Date
    July 29, 2021
    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

    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: H10 55 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 34 DEVICES WERE RECEIVED. 21 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: 55 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER, 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED UNDER MFR REPORT # 0001811755-2021-00222 BUT SHOULD BE INCLUDED UNDER THIS REPORT. 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00222. 55 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 33 DEVICES WERE RECEIVED. 19 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 3 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 55 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 49 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 55 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 49 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 6 EVENTS HAD 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: 55 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 9 DEVICES WERE RECEIVED. 15 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 31 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 55 DEVICES WERE NOT LABELED FOR SINGLE-USE. 55 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 55 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 55 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108625 ELITE 12CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5407-120-470 07613327096569

    Patients

    Seq Age Sex Outcome Treatment
    1