MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RATCHETING SMALL STRAIGHT HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was not returned, so no analysis was conducted.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the ratcheting handle was defective.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the end cap of the returned handle has been broken off and is missing.Otherwise, the tool retention and ratchet mechanisms are intact and functional.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RATCHETING SMALL STRAIGHT HANDLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8392391
• Report Number: 1723170-2019-00936
• Device Sequence Number: 1432021
• Product Code: OLO
• UDI-Device Identifier: 00763000054465
• UDI-Public: 00763000054465
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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 Number: 9733734
• Device Catalogue Number: 9733734
• Device Lot Number: 104143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1