MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM RH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6001-088-327
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the user facility in the sterile processing department the device was found with the a broken tip.No medical intervention and no adverse consequences were reported with this event.As this event did not occur during a procedure, 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.
Event or Problem Description
It was reported that at the user facility in the sterile processing department the device was found with the a broken tip.No medical intervention and no adverse consequences were reported with this event.As this event did not occur during a procedure, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: SUCTION TUBE, 2.7MM RH FRONTAL SINUS
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8357927
• Report Number: 0001811755-2019-00617
• Device Sequence Number: 206653
• Product Code: HAW
• UDI-Device Identifier: 04546540350848
• UDI-Public: 04546540350848
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/29/2019

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 Catalogue Number: 6001-088-327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1