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

Catalog Number	9734734
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon reported that after utilizing the part per manufacturer instructions, there was an unexpected navlock spin caused by the blockage of the powerease around the instrument, used to mill/shape the pedicle.The part responsible for the reported incident has not be received by the manufacturer for further analysis.
Event or Problem Description
A site representative reported that there was an unexpected navlock spin.There was no patient impact reported and no reported delay in surgery.Surgery proceeded as planned.

• Brand Name: NAVLOCK UNIVERSAL GREEN TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6282677
• Report Number: 1723170-2017-00304
• Device Sequence Number: 16288549
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• 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: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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: 9734734
• Device Lot Number: 160428
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2016
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)
• Patient Age: 47 YR
• Patient Weight: 68