• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Device Embedded In Tissue or Plaque (3165)
Event Date 08/16/2017
Event Type  Malfunction  
Event Description

It was reported that pieces of metal from the burr were coming off and leaving tiny shards in the patient. No patient injuries were reported.

 
Manufacturer Narrative

Functional inspection was performed and the inner burr did not rotate freely within the outer sheath, friction was felt in the unloaded condition. The inner burr was noted to be hitting the distal tip of the outer sheath. Galling of the inner sheath was noted opposite of the bronze bushing confirming the reported shedding. The condition of the device indicates excessive side loading took place during use causing the reported shedding. Device returned for evaluation device evaluated by the manufacturer evaluation codes updated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 drive
austin, TX 78735
MDR Report Key6821170
MDR Text Key83782368
Report Number1219602-2017-01031
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72203127
Device Catalogue Number72203127
Device LOT Number50615075
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-