• 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,4.0MM,FLAT TOP,180MM LG, HIGH VISI 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,4.0MM,FLAT TOP,180MM LG, HIGH VISI SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203130
Device Problems Particulates (1451); Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2013
Event Type  Malfunction  
Manufacturer Narrative

One used burr was returned for evaluation. Visual inspection identified significant axial fractures through the adapter body, to the outer sheath. A contact point on a section of the sheath at the end of the tube coupled with corresponding debridement of the inner tube opposite the contact point was observed. All indications point to excessive lateral load during device rotation. The device was inspected dimensionally and found to meet design requirements. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition. A review of the device history record was performed which confirmed no inconsistencies (method code 3317). After the evaluation the root cause was undetermined. The company will continue to analyze additional complaints as they are reported. (b)(4).

 
Event Description

During a hip arthroscopy it was reported that the burr was reportedly shedding in the joint. The particulate was flushed out and a backup device was available to complete the procedure. A one minute delay, no patient injuries or complications were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBURR,4.0MM,FLAT TOP,180MM LG, HIGH VISI
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
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key4945280
MDR Text Key23105381
Report Number1219602-2015-00529
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2014
Device Catalogue Number72203130
Device LOT Number50629117
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/03/2013
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-