MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK UNIVERSAL GREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/16/2019
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 from a manufacturer representative (rep) regarding a navigation instrument outside of a procedure.The rep indicated that when the instrument came back from sterilization there was a broken holding/clamping mechanism for the navlock.There was no patient involved with this issue.
Additional Manufacturer Narrative
The instrument tracker was returned to the manufacturer for evaluation.Testing found that the side tabs on the instrument had broken off.The tracker was noted to rotate and release instruments without issue and that the tracker returned good geometry and divot error readings with normal tracking.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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow-up with the manufacturer representative (rep) determined that the navlock was able to verify.

• Brand Name: NAVLOCK UNIVERSAL GREEN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8546568
• Report Number: 1723170-2019-01962
• Device Sequence Number: 373335
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2019

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: 9734734
• Device Catalogue Number: 9734734
• Device Lot Number: 161025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 07/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/17/2019; 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1