MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150 MM DISPOSABLE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733236
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The perc pin was returned to the manufacturer and is currently under analysis.
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported that the airframe did not sit flush on the perc pin, but instead rotated slightly on the pin, connections were confirmed to be tight and secure.In an attempt to resolve the issue the manufacturer representative switched out different perc pins (short and long) and 3 different airframes, which did not resolve the issue.Potential delay to procedure and patient impact are unknown at this time.
Additional Manufacturer Narrative
The analysis of the pin was completed by medtronic personnel.The pin was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.While troubleshooting in house on similar equipment, the reported issue could be replicated when an air frame, 90 degree adapter and perc pin were all used at a particular angle.It was suspected to have been caused by sufficient weight being placed on the rubber stopper of the perc pin, resulting in a loose pin.
Additional Manufacturer Narrative
The navigation system was analyzed by a manufacturing representative; there were no additional findings as a result.The hardware and software systems passed checkout.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 150 MM DISPOSABLE PIN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7813131
• Report Number: 1723170-2018-04239
• Device Sequence Number: 16761432
• Product Code: OLO
• UDI-Device Identifier: 00613994247865
• UDI-Public: 00613994247865
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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: Health Professional
• Device Model Number: 9733236
• Device Catalogue Number: 9733236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/16/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/04/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1