MAUDE Adverse Event Report: STRYKER CORPORATION CORE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5400050001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We hooked the cassette up as normal it would not irrigate properly so we took this cartridge out and put in a different cartridge and it worked perfectly, we did nothing different to the machine or the cartridge so we feel this is a defective cartridge.

• Brand Name: CORE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10520755
• Report Number: 10520755
• Device Sequence Number: 16949348
• Product Code: ERL
• UDI-Device Identifier: 04546540427298
• UDI-Public: (01)04546540427298(17)241001(10)19296022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020
• Report Date (Section F): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5400050001
• Device Catalogue Number: 5400-050-001
• Device Lot Number: 19296022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/20/2020