MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-999-002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility a piece broke off the device.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 the device was discarded by the customer, no evaluation is possible.Device discarded by customer.
Event or Problem Description
It was reported that during a procedure at the user facility a piece broke off the device.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8047767
• Report Number: 0001811755-2018-02392
• Device Sequence Number: 1786987
• Product Code: HAW
• UDI-Device Identifier: 04546540391902
• UDI-Public: 04546540391902
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 6000-999-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1