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

Catalog Number	6003-010-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the cap broke off; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during setup 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 set up, the cap broke off; this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during setup at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: FEMURAL TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8623739
• Report Number: 0001811755-2019-01756
• Device Sequence Number: 2268336
• Product Code: HAW
• UDI-Device Identifier: 04546540246011
• UDI-Public: 04546540246011
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/10/2019

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: 6003-010-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1