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

Model Number 7211010S

Device Problems Communication or Transmission Problem (2896); Pressure Problem (3012)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed transducer p1 failed the high pressure test.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

Event Description

It was reported that, during setup for surgery, the "control unit, dyonics 25" was not reading the cartridge.A backup device was available to complete the procedure.There were no procedural delays and no patient injuries or other complications were reported.Results of investigation have concluded that this unit transducer p1 failed high pressure test which makes it a reportable event.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed transducer p1 failed the high pressure test.The complaint was verified and the root cause was associated with an electronic component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the identified malfunction, include a defective pressure transducer.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.Internal complaint reference: (b)(4).

• 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
• MDR Report Key: 11850043
• MDR Text Key: 251452954
• Report Number: 1643264-2021-01904
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010555960
• UDI-Public: 03596010555960
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010S
• Device Catalogue Number: 7211010S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1