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

Catalog Number	6000-014-000
Medical Device Problem Codes	Disassembly (1168); Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure conducted at the user facility the led interface had loosened causing the navigation to be inaccurate.No adverse consequences to the patient were reported or procedural delays.
Additional Manufacturer Narrative
The reported event was confirmed through the visual inspection.Any physical impact to the navigated instrument can cause product damage or operational failure.
Event or Problem Description
It was reported that during a surgical procedure conducted at the user facility the led interface had loosened causing the navigation to be inaccurate.No adverse consequences to the patient were reported or procedural delays.

• 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: 6306679
• Report Number: 0001811755-2017-00501
• Device Sequence Number: 501278
• Product Code: OLO
• UDI-Device Identifier: 04546540651563
• UDI-Public: (01)04546540651563
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

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: 6000-014-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1