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

Model Number	6001-088-227
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility it was observed that the tip of the device was bent and caused incorrect calibration.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-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12821501
• Report Number: 3015967359-2021-02567
• Device Sequence Number: 14887257
• Product Code: HAW
• UDI-Device Identifier: 04546540245854
• UDI-Public: 04546540245854
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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
• Device Model Number: 6001-088-227
• Device Catalogue Number: 6001-088-227
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown