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

Model Number	2296033225
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was using the stryker sagittal saw blade to cut the mandible when it broke into three pieces.No resultant patient harm.

• Brand Name: NA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 25277258
• Report Number: 25277258
• Device Sequence Number: 9703298
• Product Code: GFA
• UDI-Device Identifier: 04546540047014
• UDI-Public: (01)04546540047014(17)301201(10)25335037
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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: 2296033225
• Device Catalogue Number: 2296-033-225
• Device Lot Number: 25335037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/29/2026