MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS; SAW, POWERED, AND ACCESSORIES

Catalog Number 7206011

Device Problem Output Problem (3005)

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

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Full radius shaver not functioning properly- a new shaver blade was opened.

• Brand Name: DYONICS
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10619238
• MDR Text Key: 209585117
• Report Number: 10619238
• Device Sequence Number: 1
• Product Code: HAB
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7206011
• Device Lot Number: 50832042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1