MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6000-999-004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the screw driver handle a washer broke and fell off the device.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a procedure at the user facility the screw driver handle a washer broke and fell off the device.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9875343
• Report Number: 0001811755-2020-00785
• Device Sequence Number: 16960975
• Product Code: HAW
• UDI-Device Identifier: 04546540391926
• UDI-Public: 04546540391926
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/16/2020

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: 6000-999-004
• Device Catalogue Number: 6000-999-004
• Device Lot Number: A/03/2019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1