MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PATIENT TRACKER, GREEN; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6007-005-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the tracker disassembled.The device disassembling poses the risk of a component falling into the surgical site.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4 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 the tracker disassembled.The device disassembling poses the risk of a component falling into the surgical site.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: PATIENT TRACKER, GREEN
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9447020
• Report Number: 0001811755-2019-03993
• Device Sequence Number: 11571022
• Product Code: HAW
• UDI-Device Identifier: 04546540392084
• UDI-Public: 04546540392084
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• 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): 05/27/2020

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: 6007-005-000
• Device Catalogue Number: 6007-005-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1