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

Model Number	6113119090
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Blade broke during use of surgical procedure.

• Brand Name: STRYKER PERFORMANCE SERIES
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 11965050
• Report Number: 11965050
• Device Sequence Number: 11561704
• Product Code: GFA
• UDI-Device Identifier: 04546540593290
• UDI-Public: (01)04546540593290(17)260301(10)21048017
• 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): 05/25/2021
• Report Date (Section F): 05/25/2021

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: Health Professional
• Device Model Number: 6113119090
• Device Catalogue Number: 6113119090
• Device Lot Number: 21048017
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107
• Date Report Sent to FDA: 05/25/2021