MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6003-011-000
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that a rubber gasket was missing on the device when inspected before a procedure.The gasket being detached poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Event or Problem Description
The customer observed that a rubber gasket was missing on the device when inspected before a procedure.The gasket being detached poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: POINTER, KNEE NAVIGATION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9386332
• Report Number: 0001811755-2019-03882
• Device Sequence Number: 2158266
• Product Code: HAW
• UDI-Device Identifier: 04546540246028
• UDI-Public: 04546540246028
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 6003-011-000
• Device Catalogue Number: 6003-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 11/27/2019
• 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