• 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. SVC REPL,MDU, HAND CNTRL, PWRMX 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. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Overheating of Device (1437); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2017
Event Type  malfunction  
Event Description
It was reported the powermax elite mdu hand control overheated and made a grinding noise. A back up device was utilized to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
Complaint of overheating and grinding motor noise error was confirmed. Cause of overheating and noise is a corroded motor/gearbox. The root cause of this event was identified to be associated with corrosion of the motor and gearbox assembly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
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
MDR Report Key6546268
MDR Text Key74595985
Report Number1643264-2017-00256
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-