MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FEMURAL TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6003-010-000
Medical Device Problem Codes	Computer Software Problem (1112); Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility when adjusting the jig of the device during bone placement, the software showed an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6 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 when adjusting the jig of the device during bone placement, the software showed an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: FEMURAL TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10665312
• Report Number: 0001811755-2020-02671
• Device Sequence Number: 3558778
• Product Code: HAW
• UDI-Device Identifier: 04546540246011
• UDI-Public: 04546540246011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 Model Number: 6003-010-000
• Device Catalogue Number: 6003-010-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR