BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELITE 12CM STRAIGHT ATTACHMENT

    MDR report key: 11215357 · Received January 22, 2021

    Report

    Report Number
    0001811755-2021-00222
    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. 267 EVENTS WERE ORIGINALLY REPORTED FOR THIS FAILURE MODE DURING THE REPORTING QUARTER; HOWEVER, - 1 EVENT WAS INADVERTENTLY EXCLUDED. - 268 REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 261 DEVICES WERE RECEIVED. 5 DEVICES WERE EVALUATED IN THE FIELD. 2 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 266 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER: - 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED UNDER MFR REPORT # 0001811755-2021-00223 BUT SHOULD BE INCLUDED UNDER THIS REPORT. - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2021-00223. - 1 EVENT WAS INADVERTENTLY EXCLUDED. - 267REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 55 DEVICES WERE RECEIVED. 209 DEVICES WERE EVALUATED IN THE FIELD. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 268 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 268 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 267 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 267 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: 267 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 54 DEVICES WERE RECEIVED. 208 DEVICES WERE EVALUATED IN THE FIELD. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. 4 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 267 DEVICES WERE NOT LABELED FOR SINGLE-USE. 267 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 267 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 266 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110912 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