MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES

Catalog Number 7205345

Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2013

Event Type  Malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device is not being returned. Review of the device history records were performed which confirmed no inconsistencies. There were no internal processing issues, which could have contributed to the nature of the complaint. A complaint history review has not identified additional complaints for this lot number on file. Due to this fact it is not possible to determine what may have caused the user to experience the reported incident. No further investigation is warranted at this time. (b)(4).

Event Description

It was reported during a left knee arthroscopy that the incisor plus blades was shedding in the joint. The site was flushed in an attempt to remove the shedding particulate; however, not all of the shedding was able to be removed as some was caught in the surrounding soft tissue. The procedure was completed with a backup blade on hand. The issue created a 15-20 minute delay in the case. The device was reportedly discarded post-operative, therefore nothing will be returning to the manufacturer for evaluation.

• Brand Name: BOXED INCISOR PLUS BL,(BX6)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5066014
• MDR Text Key: 25912203
• Report Number: 1219602-2015-00964
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/23/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/09/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/01/2017
• Device Catalogue Number: 7205345
• Device LOT Number: 50653003
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/23/2013
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/01/2012
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial