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

Model Number	6001-088-327
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing conducted at the user facility the tip of the device broke off.No patient involvement or procedural delays were reported to have been associated with the event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during testing conducted at the user facility the tip of the device broke off.No patient involvement or procedural delays were reported to have been associated with the event.

• 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: 6486731
• Report Number: 0001811755-2017-00846
• Device Sequence Number: 1289257
• Product Code: HAW
• UDI-Device Identifier: 04546540350848
• UDI-Public: (01)04546540350848
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K002732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: Health Professional
• Device Model Number: 6001-088-327
• Device Catalogue Number: 6001-088-327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1