MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NGENIUS FEMUR TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6003-034-000
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection the device was broken.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.H3 other text : discarded by user.
Event or Problem Description
It was reported that during inspection the device was broken.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NGENIUS FEMUR TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8932808
• Report Number: 0001811755-2019-02799
• Device Sequence Number: 11314292
• Product Code: HAW
• UDI-Device Identifier: 04546540678683
• UDI-Public: 04546540678683
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: 6003-034-000
• Device Catalogue Number: 6003-034-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1