BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 7CM STRAIGHT ATTACHMENT

    MDR report key: 10331481 · Received July 28, 2020

    Report

    Report Number
    0001811755-2020-01978
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 29, 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: 18 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. 19 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2020-01831. 18 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 13 DEVICES WERE RECEIVED. 5 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 CORRECTED DATA: H10. 18 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 13 DEVICES WERE RECEIVED. 4 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS 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 CORRECTED DATA: B5, H10 18 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER: - 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED UNDER MFR REPORT # 0001811755-2020-01927 BUT SHOULD BE INCLUDED UNDER THIS REPORT. - 19 TOTAL EVENTS WERE REPORTED FOR THIS CATALOG NUMBER/DEVICE CODE COMBINATION FOR THE REPORTING QUARTER AND ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 14 DEVICES WERE RECEIVED. 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 3 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 5 REPORTED EVENTS WERE CONFIRMED. 9 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 5 DEVICES WERE FOUND TO BE AFFECTED BY CORRODED BEARINGS. 5 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 4 DEVICE WAS FOUND TO BE AFFECTED BY LUBRICATION BREAKDOWN.

    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. 18 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 14 DEVICES WERE RECEIVED. 4 DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 18 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 14 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT. 4 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 18 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 14 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 19 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 15 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 18 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 14 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 4 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: 18 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 5 DEVICES WERE RECEIVED. 13 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 4 REPORTED EVENTS WERE CONFIRMED. 1 REPORTED EVENT WAS NOT CONFIRMED. EVALUATION RESULTS: 4 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY LUBRICATION BREAKDOWN. 18 DEVICES WERE NOT LABELED FOR SINGLE-USE. 18 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 18 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 14 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798329 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