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

Model Number	2296003511
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Md noticed the blade for the core drill was not working correctly.He removed the blade from the core drill, and it broke into three pieces on the side of the sterile field next to patient.All three pieces collected.Ctl [clinical team lead] and charge nurse notified.X-rays taken in room before closing.X-ray said it was ok for surgeon to read x-rays in room; radiologist to confirm findings.No metal detected in patient's foot.

• Brand Name: NA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage, mi 49002 MI 49002
• MDR Report Key: 25168504
• Report Number: 25168504
• Device Sequence Number: 13380476
• Product Code: GFA
• UDI-Device Identifier: 04546540046673
• UDI-Public: (01)04546540046673(17)300901(10)25239037
• 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): 05/11/2026
• Report Date (Section F): 05/11/2026

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: 2296003511
• Device Catalogue Number: 2296-003-511
• Device Lot Number: 25239037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 142 KG
• Date Report Sent to FDA: 05/11/2026