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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES Back to Search Results
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.

 
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Brand NameBOXED INCISOR PLUS BL,(BX6)
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 Key5066014
MDR Text Key25912203
Report Number1219602-2015-00964
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 05/23/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2017
Device Catalogue Number7205345
Device LOT Number50653003
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 Received05/23/2013
Was Device Evaluated By Manufacturer? No Answer Provided
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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