MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVIGATED MIS JIG - B; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6003-200-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the central sterile department of the user facility, it was discovered that the device was broken into two pieces.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.Discarded by user.
Event or Problem Description
It was reported that in the central sterile department of the user facility, it was discovered that the device was broken into two pieces.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NAVIGATED MIS JIG - B
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9460478
• Report Number: 0001811755-2019-04039
• Device Sequence Number: 11539152
• Product Code: HAW
• UDI-Device Identifier: 04546540470355
• UDI-Public: 04546540470355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2020

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: 6003-200-020
• Device Catalogue Number: 6003-200-020
• Device Lot Number: A-06-2017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1