MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-999-005
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during equipment testing conducted at the user facility the unit was found missing a part.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during equipment testing conducted at the user facility the unit was found missing a part.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7693838
• Report Number: 0001811755-2018-01168
• Device Sequence Number: 13795569
• Product Code: HAW
• UDI-Device Identifier: 04546540391933
• UDI-Public: 04546540391933
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6000-999-005
• Device Lot Number: C/10/2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1