MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL,CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205335

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/14/2019

Event Type  malfunction  

Event Description

It was reported that during procedure, it was found that label states item is a concave, but it is actually a convex blade.The device was used on the patient.A backup device was available to complete the procedure with no delay and no patient injuries.

Manufacturer Narrative

The reported full radius blade concave blades were not returned for evaluation.A trend of this nature has been observed with this product in the field, prompting a corrective action investigation.This error results in the cutting window being located incorrectly relative to the bend.As an immediate response to this complaint, a quality alert was issued and a retraining of the machine operators to the manufacturing process was performed.In addition a root cause investigation has been opened to address this failure mode.

• Brand Name: FULL RADIUS BL,CONCAVE EP-1 (BX 3)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8762800
• MDR Text Key: 150138025
• Report Number: 1219602-2019-00783
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: 7205335
• Device Lot Number: 50779861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1