• 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. SVCE REPL 3RD ED. C/U S&N DYONICS 25 ARTHROSCOPE

  • 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. SVCE REPL 3RD ED. C/U S&N DYONICS 25 ARTHROSCOPE Back to Search Results
Catalog Number 7211010S3E
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Joint Swelling (2356)
Event Date 10/17/2016
Event Type  malfunction  
Event Description
It was reported that the dyonics 25 control unit caused fluid build-up in the shoulder joint of the patient during a rotator cuff repair surgery. A backup device was used to complete the procedure. A delay of less than 30 minutes was noted. No injury or complications were reported.
 
Manufacturer Narrative
Complaint of pressure malfunction could not be reproduced. Product passed functional testing during 2 hour burn-in on wet station utilizing low and high pressure and flow settings with no faults or errors. At no time during functional testing did pump pressure fluctuate. A review of the service device history record for this device shows that this unit passed all acceptance criteria and no inconsistencies were found. After the evaluation the root cause for the reported issue could not be determined as the malfunction could not be reproduced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSVCE REPL 3RD ED. C/U S&N DYONICS 25
Type of DeviceARTHROSCOPE
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 dr.
austin, TX 78735
5123585706
MDR Report Key6058879
MDR Text Key58665317
Report Number1643264-2016-00197
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051326
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 10/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211010S3E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-