MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	7700-800-000
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	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon's depth to seat numbers were increasing when thy impacted the cup deeper as opposed to decreasing.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the surgeon's depth to seat numbers were increasing when thy impacted the cup deeper as opposed to decreasing.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.

• Brand Name: STRYKER NAV3I(TM) PLATFORM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8785902
• Report Number: 0001811755-2019-02274
• Device Sequence Number: 1926256
• Product Code: OLO
• UDI-Device Identifier: 07613327004250
• UDI-Public: 07613327004250
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 12/12/2019

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: 7700-800-000
• Device Lot Number: VERSION 2.0-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1