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

Model Number 6113119090

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

Left knee arthroplasty.Narrow sagittal saw blade broke while doctor was completing the femoral cut.

• Brand Name: STRYKER PERFORMANCE SERIES
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 15612123
• MDR Text Key: 301822480
• Report Number: 15612123
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540593290
• UDI-Public: (01)04546540593290(17)270401(10)22104017
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6113119090
• Device Catalogue Number: 6113-119-090
• Device Lot Number: 22104017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female