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 Codes	Image Display Error/Artifact (1304); Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user facility that during a procedure, there was an inaccuracy by the device, and at one point the inaccuracy was 15mm.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 procedure, there was an inaccuracy by the device, and at one point the inaccuracy was 15mm.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: 8736500
• Report Number: 0001811755-2019-02119
• Device Sequence Number: 16712097
• Product Code: PGW
• UDI-Device Identifier: 07613327004250
• UDI-Public: 07613327004250
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/15/2019

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 2.0-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1