• 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
Model Number 72200616S
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information received.
 
Manufacturer Narrative
There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Product passed functional and high speed testing (100-10,000 rpms) for 10 minutes in both forward and reverse directions. Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch. Current draw was average for this product and overheating did not occur during functional testing. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.
 
Event Description
It was reported that the device overheats. No significant delay or patient injury reported.
 
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 west william cannon drive
MDR Report Key6889002
MDR Text Key117304959
Report Number1643264-2017-00570
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,Followup
Report Date 12/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200616S
Device Catalogue Number72200616S
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 Received12/22/2017
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 Reuse

-
-