MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NGENIUS UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6000-014-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility the metal piece that the tracker connects to the instrumentation is loose, which could cause an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility the metal piece that the tracker connects to the instrumentation is loose, which could cause an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.Device discarded by user.

• Brand Name: NGENIUS UNIVERSAL TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8102697
• Report Number: 0001811755-2018-02549
• Device Sequence Number: 2017908
• Product Code: OLO
• UDI-Device Identifier: 04546540651563
• UDI-Public: 04546540651563
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: Health Professional
• Device Catalogue Number: 6000-014-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1