MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440365

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Oscillating saw blade fanned 1.27mmx 19mm, ref number (b)(4), lot 22bgr1517a broke while being used by the surgeon.Made sure that all the pieces were retrieved from the saw handpiece.A new blade was opened.

• Brand Name: NA
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 16183670
• MDR Text Key: 307478300
• Report Number: 16183670
• Device Sequence Number: 1
• Product Code: HRY
• 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: 01/10/2023

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
• Device Model Number: 71440365
• Device Catalogue Number: 71440365
• Device Lot Number: 22BGR1517A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1