MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC HANDLE RATCHETING; 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	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system while outside of procedure.It was reported that the ratcheting handle was damaged.The upper metal cap was loose and lost.There was no patient present when the issue occurred.

• Brand Name: HANDLE RATCHETING
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8714761
• Report Number: 1723170-2019-03628
• Device Sequence Number: 16810144
• Product Code: OLO
• UDI-Device Identifier: 00643169089600
• UDI-Public: 00643169089600
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 70615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1