MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) RIGHT TACTILE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9730818
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Part not returned.
Event or Problem Description
A medtronic representative reported that the instrument was causing inaccuracies during navigation.There was no patient impact or delay in surgery reported.Surgery proceeded as planned.
Additional Manufacturer Narrative
The hardware investigation of the returned probe found that the reported event was related to a physical damage issue.The returned probe was visibly bent at the tip.With a known good tracker attached, the probe returned a high divot error above 3.0 mm that would not allow verification.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: RIGHT TACTILE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6440735
• Report Number: 1723170-2017-01337
• Device Sequence Number: 783425
• Product Code: OLO
• UDI-Device Identifier: 00721902984419
• UDI-Public: 00721902984419
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: Health Professional
• Device Catalogue Number: 9730818
• Device Lot Number: 110418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1