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

Model Number 6118127090

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Patient presented to the operating room for a right total knee replacement.During the procedure, the saw blade that was being used broke while in use within the capsule of the joint.All pieces of the broken saw blade were recovered and removed from the field, and a new blade was opened.The staff in the room attempted to find the packaging for the faulty blade in the garbage cans, but we were unsuccessful in finding it.

• Brand Name: STRYKER PERFORMANCE SERIES
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 16973996
• MDR Text Key: 315670934
• Report Number: 16973996
• Device Sequence Number: 1
• Product Code: GFA
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6118127090
• Device Catalogue Number: 6118-127-090
• 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: 05/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male