MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES

Catalog Number 7210976

Device Problem Particulates (1451)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/20/2012

Event Type  Malfunction  

Manufacturer Narrative

One used blade was returned for evaluation. The returned blade assembly was evaluated for shedding. The inner and outer blade subassemblies were evaluated for dimensional conformance and found to meet design specification for total indicated runout of the subassemblies. The outer blade tip and tube alignment were within specification. However, it was observed that there was a significant degree of splay at the inner blade edge form. This splay is typically caused by the stresses induced in the blade tip, during forming, and released once the edge form is cut into the tip. The splay caused a reduction in the gap between the inner and outer blade tips resulting in friction and galling of the material, leading to shedding. A change to the fabrication process for the inner blade has been affected which eliminates the splay condition. Additionally, steps at the assembly process have been initiated to screen for blade friction prior to packaging. A review of the device history record was performed which confirmed no inconsistencies. The device was built to the then current specifications. After the evaluation, the root cause was determined to be a manufacturing issue which has since been addressed. The company will continue to analyze additional complaints as they are reported. (b)(4).

Event Description

During an ankle arthroscopy procedure, it was reported that loose particles were seen in the joint space. The particles were removed but it cannot be guaranteed that none of the particles remained. The procedure was completed with a backup device on hand. It was later reported that the surgeon did not indicate that any debris was noted (remaining in the site). No significant time delay or patient injury was reported.

• Brand Name: INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
• 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: 4974084
• MDR Text Key: 23826790
• Report Number: 1219602-2015-00725
• 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: 01/14/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/05/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2017
• Device Catalogue Number: 7210976
• Device LOT Number: 50658303
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/28/2013
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/18/2013
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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