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

Model Number	6000-007-000
Medical Device Problem Codes	Image Display Error/Artifact (1304); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, it was observed that a component was loose and still intact which could lead to inaccuracies.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Event or Problem Description
It was reported that, during use, it was observed that a component was loose and still intact which could lead to inaccuracies.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• 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: 8956759
• Report Number: 0001811755-2019-02899
• Device Sequence Number: 2521119
• Product Code: HAW
• UDI-Device Identifier: 04546540245052
• UDI-Public: 04546540245052
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 Model Number: 6000-007-000
• Device Catalogue Number: 6000-007-000
• Device Lot Number: C-04-2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1