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

Model Number 0277096277

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

During a total knee arthroscopy procedure the saw blade broke.All pieces recovered and removed from the sterile field.

• Brand Name: NA
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10390123
• MDR Text Key: 202375961
• Report Number: 10390123
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540880703
• UDI-Public: (01)04546540880703
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0277096277
• Device Catalogue Number: 0277096277
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA