MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® EXPRESS KNEE 2.0 SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6003-672-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the device was inaccurate, the inaccuracy allegedly resulted in the first cut being inaccurate, and the patient having their femoral cut in valgus.The doctor was able to identify the error and corrected with a second cut using traditional instrumentation.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.
Event or Problem Description
It was reported that during a procedure at the user facility the device was inaccurate, the inaccuracy allegedly resulted in the first cut being inaccurate, and the patient having their femoral cut in valgus.The doctor was able to identify the error and corrected with a second cut using traditional instrumentation.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: ORTHOMAP® EXPRESS KNEE 2.0 SOFTWARE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7931049
• Report Number: 0001811755-2018-01707
• Device Sequence Number: 11241310
• Product Code: HAW
• UDI-Device Identifier: 04546540717450
• UDI-Public: 04546540717450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/25/2019

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: 6003-672-000
• Device Lot Number: VERSION: 2.0-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1