• 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. DYONICS 5.5MM ELITE ABRADER BURR 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. DYONICS 5.5MM ELITE ABRADER BURR SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200723
Device Problem Metal Shedding Debris (1804)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/07/2017
Event Type  Malfunction  
Event Description

It was reported that metal shavings were coming off into the joint.

 
Manufacturer Narrative

A visual assessment identified a significant axial fracture through the adapter body, to the outer blade. Contact points were identified on the inner burr coupled with corresponding debridement of the outer sheath. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition. The device was inspected dimensionally and found to meet design requirements. All indications point to excessive lateral load during use. Per the devices ifu ¿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 further investigation is warranted at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDYONICS 5.5MM ELITE ABRADER BURR
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
5123585706
MDR Report Key6423460
MDR Text Key70769201
Report Number1219602-2017-00320
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200723
Device LOT Number50979268
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2017
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

-
-