MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	6007-616-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user facility that during a leg length verification post procedure, there was an inaccuracy by the device.The device reflected a length that was longer than the actual length.The exact inaccuracy was unknown, but less than 11mm.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 by the user facility that during a leg length verification post procedure, there was an inaccuracy by the device.The device reflected a length that was longer than the actual length.The exact inaccuracy was unknown, but less than 11mm.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8362670
• Report Number: 0001811755-2019-00638
• Device Sequence Number: 19359470
• Product Code: PGW
• UDI-Device Identifier: 07613327004250
• UDI-Public: 07613327004250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 6007-616-000
• Device Lot Number: VERSION: 2.0-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1