BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR MR8 ELECTRIC

    MDR report key: 13590054 · Received February 24, 2022

    Report

    Report Number
    1625507-2022-00029
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT CONFIRMED. THE DEVICE WAS TESTED AND THE MAXIMUM TEMPERATURE WAS MEASURED TO BE 147.56°F. THE LIKELY CAUSE OF FAILURE COULD NOT BE DETERMINED. IT WAS ALSO NOTED ENGRAVING OF THE COLLET PART DETERIORATED. DEVICE HISTORY RECORD # (B)(4) WAS REVIEWED AND DID NOT REFLECT ANY CONDITIONS RELATED TO THE CURRENT, REPORTED MALFUNCTION. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS THAT HEAVY SIDE LOADS AND/OR LONG OPERATING TIMES MAY CAUSE THE DEVICE TO OVERHEAT. IF THE DEVICE OVERHEATS, DISCONTINUE USE AND REST THE DEVICE BY USING IT INTERMITTENTLY, OR WRAP THE DEVICE IN A MOIST STERILE TOWEL. USE OF AN OVERHEATED DEVICE MAY CAUSE INJURY TO THE PATIENT OR OPERATOR. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CORRECTION: MISSING PMA / 510(K) # NUMBER IN THE INITIAL MDR ADDED: PMA / 510(K): K183515 . MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.. ON FOLLOW-UP, NO FURTHER INFORMATION WAS PROVIDED ON PATIENT IMPACT. DATE OF NOTIFICATION: (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107090 MOTOR MR8 ELECTRIC MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS EM800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown