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

Model Number	6113119090
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the patient's left total knee arthroplasty, it was noticed there was a small, crescent-sized piece of metal missing from a used saw blade.Searches in and around the field produced no results.X-ray was taken, radiologist stated he could not find any radiopaque foreign body of the description.Rest of the surgery concluded with no further incident.

• 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: 21228610
• Report Number: 21228610
• Device Sequence Number: 12847381
• Product Code: GFA
• UDI-Device Identifier: 04546540593290
• UDI-Public: (01)04546540593290(17)290901(10)24253097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2025
• Report Date (Section F): 01/13/2025

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: 6113-119-090
• Device Lot Number: 24253097
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• 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
• Patient Age: 1 MO
• Patient Sex: Female
• Date Report Sent to FDA: 01/13/2025