MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PERCUTANEOUS REFERENCE CROSS PIN FRAME; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9732353
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.The suspect reference frame was returned to the manufacturer for analysis.It was reported that the push button on the base of the unit was disengaged.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
Event or Problem Description
A medtronic representative reported that, while outside of a procedure, the per reference frame pin was handle/stem was reported to have been damaged.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Lot number and device manufacturer date provided.

• Brand Name: PERCUTANEOUS REFERENCE CROSS PIN FRAME
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6768288
• Report Number: 1723170-2017-03186
• Device Sequence Number: 19324622
• Product Code: OLO
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: Physician
• Device Catalogue Number: 9732353
• Device Lot Number: 7040614523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1