MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL CONTROL UNIT DYONICS 25; ARTHROSCOPE

Catalog Number 7211010S

Device Problems Melted (1385); Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2016

Event Type  malfunction  

Event Description

It was reported that the front panel of the dyonics 25 control unit shorted out and the plastic melted.This occurred before a knee procedure, and the procedure was completed using a backup device.No injury or complications were reported.

Manufacturer Narrative

Complaint of shorted out pump with melted front bezel was confirmed.It appears that a short occurred around the screw mounts on front bezel, display frame, and the display.Cause of short is a leak inside of bezel which appears to be saline fluid.Bezel bracket has residue of saline solution around screw holes and top lip.The saline solution shorted out the display, conductive coating on the inside of front bezel, and chassis ground.The conductive coating on inside of front bezel caused multiple areas around display frame to melt.The resulting short also melted plastic around both bezel and frame screw mounts.The complaint investigation has concluded that this unit has succumbed to a short caused by a saline leak on front bezel.A review of manufacturing records shows this unit passed all acceptance criteria and was compliant upon release for distribution on or about december 09, 2014.After the evaluation the root cause for the reported issue was determined to be off-label use.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL CONTROL UNIT DYONICS 25
• Type of Device: ARTHROSCOPE
• 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 Key: 6169982
• MDR Text Key: 62673059
• Report Number: 1643264-2016-00280
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211010S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1