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

Model Number	6118127110
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While doing a total knee surgery, a stryker blade was broken at the blade insertion point.This was observed by operating room tech on the field.Surgeon was notified and the broken piece was identified and both the blade and the blade fragment were delivered to management.A post op x-ray was ordered by surgeon.

• Brand Name: STRYKER PERFORMANCE SERIES
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 22736778
• Report Number: 22736778
• Device Sequence Number: 9103914
• Product Code: GFA
• UDI-Device Identifier: 04546540593382
• UDI-Public: (01)04546540593382
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/31/2025
• Report Date (Section F): 07/31/2025

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: 6118127110
• Device Catalogue Number: 6118-127-110
• Device Lot Number: 24183037
• 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: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/31/2025