MAUDE Adverse Event Report: STRYKER CORPORATION; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	5301020061S1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, the blades broke and snapped in two.Second blade inserted with the same results.

• Brand Name: NA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 4100 e. milham; kalamazoo MI 49001
• MDR Report Key: 8338951
• Report Number: 8338951
• Device Sequence Number: 16707559
• Product Code: GFA
• UDI-Device Identifier: 07613153095606
• UDI-Public: (01)07613153095606
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/11/2019
• Report Date (Section F): 02/11/2019

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: 5301020061S1
• Device Catalogue Number: 5301020061S1
• Device Lot Number: 18052027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2019
• 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: 02/11/2019