MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORE 2 CONSOLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400052000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the equipment kept running during set up for a procedure.Multiple cords and handpieces were tested.This console is the only one that created a run- on condition.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the end user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
The device was returned for evaluation.Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the equipment kept running during set up for a procedure.Multiple cords and handpieces were tested.This console is the only one that created a run- on condition.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the end user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: CORE 2 CONSOLE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19481095
• Report Number: 3015967359-2024-01117
• Device Sequence Number: 20845058
• Product Code: ERL
• UDI-Device Identifier: 07613327298505
• UDI-Public: 07613327298505
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 5400052000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown