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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES Back to Search Results
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.

 
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Brand NameINCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
Type of DeviceSAW, 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 Key4974084
MDR Text Key23826790
Report Number1219602-2015-00725
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
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 Received08/05/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device Catalogue Number7210976
Device LOT Number50658303
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2013
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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