MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK TRACKER UNIVERSAL GREY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734590
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medtronic representative reported that it was suspected that the issue was being caused by the part being over heated due to the metal rubbing against metal while the parts were rotating; the issue could have been avoided by using sterile lubrication.The surgeon used a new part and lowered the rpm which resolved the issue during the case.The part was replaced.A successful system checkout was performed which verified that the issue had been resolved.The replaced tracker was sent to the manufacturer for part analysis.During part analysis there was a confirmed mechanical failure with the tracker.This issue was documented in a medtronic navigation hardware tracking database.
Event or Problem Description
A site representative reported that during a spinal fusion cervical case, while using the powerease motor, the part became jammed.There was no patient impact reported and the delay in surgery was less than an hour.Surgery proceeded as planned.

• Brand Name: NAVLOCK TRACKER UNIVERSAL GREY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7228509
• Report Number: 1723170-2018-00453
• Device Sequence Number: 19128970
• Product Code: OLO
• UDI-Device Identifier: 00643169085534
• UDI-Public: 00643169085534
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/30/2018

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: 9734590
• Device Lot Number: 120330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 67