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

Model Number 7211010

Device Problem Pressure Problem (3012)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that, the "dyonics 25 control unit" had different pressure readings outside the permitted tolerance from p1 and p2 sensors.It is unknown if the event happened during surgery.Therefore, no patient involvement or surgical complications could be confirmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the reported device, used 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 lid and bezel were scratched and dented.Complaint of incorrect pressure readings could not be confirmed.Product failed functional testing with a blank touchscreen after power up.No further functional testing could be performed.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.The device has been in service for over 13 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.

Manufacturer Narrative

B5: event description updated.

Event Description

It was reported that, during a shoulder arthroscopy, the "dyonics 25 control unit" had different pressure readings outside the permitted tolerance from p1 and p2 sensors.The procedure was successfully completed without delay using the same device.No patient injuries or other complications were reported.

• 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: 10242402
• MDR Text Key: 197987770
• Report Number: 1643264-2020-00485
• 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,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1