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

Model Number	6003-200-010
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a product demonstration event, a piece broke off from the device.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
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 after a product demonstration event, a piece broke off from the device.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NAVIGATED MIS JIG - A
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10705263
• Report Number: 0001811755-2020-02746
• Device Sequence Number: 2988615
• Product Code: HAW
• UDI-Device Identifier: 04546540470348
• UDI-Public: 04546540470348
• 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): 02/17/2021

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: 6003-200-010
• Device Catalogue Number: 6003-200-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1