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

Catalog Number 72200873F

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the dyonics power ii controller presented a white screen on start-up and was not functioning.A backup was available to complete the procedure.There was no reported delay in the procedure or patient impact associated with this event.

Manufacturer Narrative

Device investigation narrative - the subject device was not returned for evaluation to the designated complaint unit, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Factors unrelated to the manufacturing and design of the device, which could have contributed to the reported event, includes a defective control board or power supply.Manufacturing records show that the refurbished device was released to distribution on january of 2016.There are no indications to suggest that the product did not meet manufacturing specification when released to distribution.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.(b)(4).

Manufacturer Narrative

Complaint of white screen on power up was confirmed.Cause of display malfunction is a defective display assembly.The complaint investigation has concluded the cause of the failure to be a defective electronic component.

• Brand Name: RFB, DYONICS POWER II CONTROL UNIT
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6002832
• MDR Text Key: 57255502
• Report Number: 1643264-2016-00186
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200873F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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