MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP DYONICS POWER II CONTROL UNIT; ARTHROSCOPE

Model Number 72200873S

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during procedure, the dyonics power ii control unit caught fire.The procedure was completed with a backup device with no delay.No patient complications were reported.It is unknown what procedure was being performed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.Complaint of overheating was confirmed.Cause of overheating is a defective touchscreen.Touchscreen shorted out and is partially burnt.The complaint investigation has concluded the cause of the failure to be a defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REP DYONICS POWER II CONTROL UNIT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11712814
• MDR Text Key: 247249346
• Report Number: 1643264-2021-01520
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010615411
• UDI-Public: 03596010615411
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200873S
• Device Catalogue Number: 72200873S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1