MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6001-088-227
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility, the device was found to be bent and non functional after colliding with a drill during the procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
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 device was found to be bent and non functional after colliding with a drill during the procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7931394
• Report Number: 0001811755-2018-01714
• Device Sequence Number: 1936350
• Product Code: HAW
• UDI-Device Identifier: 04546540245854
• UDI-Public: 04546540245854
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/11/2019

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: 6001-088-227
• Device Lot Number: 10745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1