MAUDE Adverse Event Report: DEROYAL #15 SCALPEL SWANN MORTON

Device Problem Fracture (1260)

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

Event Date 11/24/2017

Event Type  malfunction  

Event Description

A #15 scalpel blade fractured during surgical procedure.Required use of fluoroscopic to locate remaining piece in right foot 1st mpj area.Caused a 30 minute delay locating scalpel fragment.Piece was located and removed.Diagnosis or reason for use: bunionectomy.

• Brand Name: #15 SCALPEL SWANN MORTON
• Type of Device: #15 SCALPEL
• Manufacturer (Section D): DEROYAL
• MDR Report Key: 7078954
• MDR Text Key: 93731210
• Report Number: MW5073708
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR