MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADAPTER FOR FIXATION OF UNIVERSAL TRACKER TO MAYFIELD CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-007-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the device is not staying tight, which could lead to inaccuracies.The procedure was completed successfully with the same device 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 is not staying tight, which could lead to inaccuracies.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: ADAPTER FOR FIXATION OF UNIVERSAL TRACKER TO MAYFIELD CLAMP
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7925896
• Report Number: 0001811755-2018-01706
• Device Sequence Number: 16720697
• Product Code: HAW
• UDI-Device Identifier: 04546540245052
• UDI-Public: 04546540245052
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/16/2019

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: Health Professional
• Device Catalogue Number: 6000-007-000
• Device Lot Number: A/07/2013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1