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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,3.5 BONE CUTTER FULL RADIUS,DISP SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BLADE,3.5 BONE CUTTER FULL RADIUS,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7210486
Device Problem Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2013
Event Type  Malfunction  
Manufacturer Narrative

The blade was returned. The device was evaluated microscopically and there was little to no evidence of galling at the inner blade tip. However, it was observed that the silver plating at the tips had delaminated. A review of the device history record was performed which confirmed no inconsistencies (b)(4). After the evaluation a root cause could not be determined. The company will continue to analyze additional complaints as they are reported. (b)(4).

 
Event Description

During a knee arthroscopy procedure it was reported that the device started shedding. The particulate was removed via suction with a shaver. There was a ten minute delay and no patient injury reported. A backup device was on hand.

 
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Brand NameBLADE,3.5 BONE CUTTER FULL RADIUS,DISP
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 Key4942489
MDR Text Key23011470
Report Number1219602-2015-00487
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2018
Device Catalogue Number7210486
Device LOT Number50710671
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2013
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/28/2013
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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