• 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. MINI MOTOR DRIVE UNIT EP-1 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. MINI MOTOR DRIVE UNIT EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205357
Device Problems Positioning Problem (3009); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023); Handpiece (3067)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2019
Event Type  Malfunction  
Manufacturer Narrative

Foreign zip code: (b)(6).

 
Event Description

It was reported that during ankle arthroscopy, the handpiece was heating, it was noticed that the inner blade did not rotate. Another console was used but the issue still remained. The console was reset and the port was changed but the handpiece did not work. The procedure was successfully completed without considerable delay using a back-up device. No patient injury or other complications were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMINI MOTOR DRIVE UNIT EP-1
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8487835
MDR Text Key141206324
Report Number1643264-2019-00255
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeMX
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7205357
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-