MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6003-655-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the software showed an inaccuracy of implant placement, while final x-rays were able to verify the implant placement was accurate.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 during a procedure at the user facility the software showed an inaccuracy of implant placement, while final x-rays were able to verify the implant placement was accurate.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 the data log files were not available for inspection, no evaluation is possible.

• Brand Name: ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8357831
• Report Number: 0001811755-2019-00614
• Device Sequence Number: 2284664
• Product Code: HAW
• UDI-Device Identifier: 04546540717443
• UDI-Public: 04546540717443
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K022579
• 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): 05/20/2019

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 Catalogue Number: 6003-655-000
• Device Lot Number: VERSION 5.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1