• 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 Problem Circuit Failure (1089)
Patient Problem No Patient Involvement (2645)
Event Date 03/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported a short circuit on the device. No patient involved as the failure was found before the surgery. There were no overheating, sparking , error message or smoke reported.
 
Manufacturer Narrative
Additional information was received stating that the event did not result in an overheating, sparking, error message or smoking of the device. Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8520551
MDR Text Key142335734
Report Number1643264-2019-00278
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeKS
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 05/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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

-
-