MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AWL; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6002-700-000
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set-up conducted at the user facility the black lens of the device popped off.No patient involvement or procedural delays were reported with this event.
Additional Manufacturer Narrative
The reported event that the black lens popped off the device was confirmed through the device inspection.During the visual inspection it was observed that the large led lens is broken off.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
Event or Problem Description
It was reported that during set-up conducted at the user facility the black lens of the device popped off.No patient involvement or procedural delays were reported with this event.

• Brand Name: AWL
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6331419
• Report Number: 0001811755-2017-00587
• Device Sequence Number: 1564454
• Product Code: HAW
• UDI-Device Identifier: 04546540387448
• UDI-Public: (01)04546540387448
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K012380
• 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,Followup
• Report Date (Section B): 03/15/2017

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: Other
• Device Catalogue Number: 6002-700-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1