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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 4.0 ABRADER 180 LG HIGH VIS DSPL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BURR 4.0 ABRADER 180 LG HIGH VIS DSPL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203128
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2017
Event Type  malfunction  
Event Description
It was reported that the burr started shedding during use and that there was not any excessive burring by the doctor. It was still removing tissue but it had to have been rubbing internally thus causing shedding in the joint. There was no significant delay or patient injury reported.
 
Manufacturer Narrative
The complaint is listed as ¿the burr started shedding during use and that there was not any excessive burring by the doctor. It was still removing tissue but it had to have been rubbing internally thus causing shedding in the joint¿. This is a large burr which will excise material more aggressively than another style or smaller sized device. There is light skiving on the outer diameter of the inner blade surface. There are dings and small gouges on the spherical blade surfaces. Excessive ¿side-loading¿ on the blade during use in extreme cases may result in wear and degradation of the inner assembly. User error may have been a contributing factor to this event.
 
Event Description
It was reported that the device burred excessively. There was no delay or patient injury reported.
 
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Brand NameBURR 4.0 ABRADER 180 LG HIGH VIS DSPL
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6901087
MDR Text Key115138077
Report Number1219602-2017-01218
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Catalogue Number72203128
Device Lot Number50658915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2017
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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