MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR SHARP PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-553
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device not returned.
Event or Problem Description
A medtronic representative reported that during a spinal fusion procedure the tip of the passive planar sharp was discovered to be bent.It was unknown if the instrument was bent while in use or during instrument verification.There was no delay or impact to the outcome of the patient.
Additional Manufacturer Narrative
The suspect probe was returned to the manufacturer for evaluation.The probe found that the arm of the array was bent.A high geometry error was found due to the bent support arm for the marker.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: PASSIVE PLANAR SHARP PROBE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6433912
• Report Number: 1723170-2017-01351
• Device Sequence Number: 16333620
• Product Code: HAW
• UDI-Device Identifier: 00673978090108
• UDI-Public: 00673978090108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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: 960-553
• Device Lot Number: 081113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1