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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
Catalog Number 72203127
Device Problems Device Inoperable (1663); Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913); Temperature Problem (3022); Noise, Audible (3273)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
H3: device investigation narrative - this blade is used. The sluff chamber area is damaged and beginning to melt. Per the ifu: ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site. Ensure that suction of 128 mmhg minimum is flowing while the instrument is running. ¿ and it also states: ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry). ¿ this device was manufactured in mexico. We have ceased manufacturing at the mexico location. No further investigation is warranted at this time.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the burr made a screeching sound, was catching and shedding metal. The handpiece became hot and stopped working. The same occurred with the second and third burrs from the box (same batch). A device of a new batch was tried and worked fine. All of the fine metal shavings were removed from the patient with suction.
 
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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 w. william cannon
austin, TX 78735
MDR Report Key6693307
MDR Text Key141602888
Report Number1219602-2017-00716
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2018
Device Catalogue Number72203127
Device Lot Number50925547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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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