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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72203127
Device Problem Metal Shedding Debris (1804)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Device investigation narrative - two 5. 5 abrader burrs were returned for evaluation. Visual assessment of the devices show the inner burrs are dramatically bent, it appears the burrs were purposely bent. The inner burrs also show visible signs of material galling and debridement. The bushing is scored and there is corresponding debridement of the outer sheath. The condition of the devices indicate an excessive lateral load was placed on them during use. Per the devices ifu 1060595 ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿. No root cause related to the manufacture of the device can be established. Further investigation is not warranted at this time. (b)(4).
 
Event Description
It was reported that the burrs were causing metal flaking during the procedure. A backup device was available to complete the procedure without any patient impact. There was a short delay reported.
 
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Brand NameBURR 5.5 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 Key6836349
MDR Text Key144425168
Report Number1219602-2017-01054
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 distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date09/30/2019
Device Model Number72203127
Device Catalogue Number72203127
Device Lot Number50656379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
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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