BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HD 14CM STRAIGHT ATTACHMENT

    MDR report key: 9637284 · Received January 28, 2020

    Report

    Report Number
    0001811755-2020-00316
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    December 31, 2019
    Report Date
    July 29, 2021
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327096675
    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 15 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2020-00314. - 14 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 7 DEVICES WERE RECEIVED. 7 DEVICES WERE NOT AVAILABLE FOR EVALUATION. EVENT CONFIRMATION STATUS 4 REPORTED EVENTS WERE CONFIRMED. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 5 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION. 1 DEVICE WAS FOUND TO BE AFFECTED BY A LACK OF LUBRICATION.

    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: H6 (METHOD, RESULTS, AND CONCLUSION CODE GRIDS).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H10 17 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER:  - 1 EVENT WAS REPORTED IN ERROR. - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT #0001811755-2020-00314. 15 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 7 DEVICES WERE RECEIVED. 7 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 4 REPORTED EVENTS WERE CONFIRMED. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 5 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION. 1 DEVICE WAS FOUND TO BE AFFECTED BY A LACK OF LUBRICATION.

    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 17 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 6 DEVICES WERE RECEIVED. 11 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 3 REPORTED EVENTS WERE CONFIRMED. 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 5 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 15 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 15 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 17 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 17 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: 17 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 3 DEVICES WERE RECEIVED. 14 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 3 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS: 3 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. ADDITIONAL INFORMATION: 17 DEVICES WERE NOT LABELED FOR SINGLE-USE. 17 DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 17 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 16 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
    102302 HD 14CM STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO 5407-120-070 07613327096675

    Patients

    Seq Age Sex Outcome Treatment
    1