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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT 3.5MM,EP-1,DISP BLD SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. RAZORCUT 3.5MM,EP-1,DISP BLD SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205317
Device Problem Particulates (1451)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6).

 
Event Description

It was reported that at the end of a knee scope using the razorcut 3. 5mm blade the surgeon noticed dust like particles in the patient. No information has been provided regarding any surgical delay or interventional actions taken as a result of the alleged findings. No patient injury was reported as a result of the alleged event.

 
Manufacturer Narrative

Device investigation narrative - two used and one unused 3. 5mm razorcut blades were returned for evaluation. Visual assessment of the used blades using a stereo microscope showed surface scoring, however no visible evidence of material galling or debridement was observed. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt on all devices. Each blade was evaluated for dimensional conformance and found to meet specifications. No root cause related to the manufacturing process can be established. Further investigation is not warranted at this time. Device returned for evaluation. Device evaluated by the manufacturer. Evaluation codes updated. (b)(4).

 
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Brand NameRAZORCUT 3.5MM,EP-1,DISP BLD
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
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key5573734
MDR Text Key42536996
Report Number1219602-2016-00190
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation SERVICE PERSONNEL
Type of Report Initial,Followup
Report Date 03/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2020
Device Catalogue Number7205317
Device LOT Number50921744
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/13/2016 Patient Sequence Number: 1
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