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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RATCHETING HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC RATCHETING HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733734
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Report source foreign country: (b)(6).No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the ratchet handle broke.There was no delay to the case.No impact on patient outcome.
 
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Brand Name
RATCHETING HANDLE
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key9733951
Report Number1723170-2020-00582
Device Sequence Number3270025
Product Code OLO
UDI-Device Identifier00763000054465
UDI-Public00763000054465
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K124004
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number9733734
Device Catalogue Number9733734
Device Lot Number106569
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date02/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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