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

Model Number 7211010

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that, during a meniscus repair, the pump machine to regulate the pressure "control unit (dyonics 25)" had an error.So, there was continuous bleeding, even though a tourniquet was performed.The procedure was completed without significant delay using a back-up device.No additional complications were reported.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 not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of the instructions for use recommends that the use of accessories, transducers and cables with this equipment, other than those specified or provided by the smith & nephew, could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.Do not place the dyonics 25 system control unit above any electrical or electronic equipment that may be damaged by a spill.Use only one finger at a time when operating the lcd touch screen.Multiple, simultaneous finger presses can result in unintended changes to settings and erroneous control inputs.A review of risk management files found that the reported failure was documented appropriately.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: CONTROL UNIT DYONICS 25
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10823976
• MDR Text Key: 215892767
• Report Number: 1643264-2020-01775
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 03596010543554
• Combination Product (y/n): N
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Device Lot Number: ZN20531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 02/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention