MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER; SAW, POWERED, AND ACCESSORIES

Catalog Number	0940000000
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after a procedure at the user facility that the device would not turn off.The procedure was completed successfully without a clinically significant delay.No adverse consequences were associated with this event.
Additional Manufacturer Narrative
Supplemental submitted to document device evaluation.
Event or Problem Description
It was reported after a procedure at the user facility that the device would not turn off.The procedure was completed successfully without a clinically significant delay.No adverse consequences were associated with this event.

• Brand Name: CAST CUTTER
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8323288
• Report Number: 0001811755-2019-00519
• Device Sequence Number: 2358013
• Product Code: HAB
• UDI-Device Identifier: 07613327115147
• UDI-Public: 07613327115147
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 0940000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1