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

Catalog Number 7211010

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during a rotator cuff repair surgery, the dyonics 25 control unit had a cassette insertion error.Since no back-up device was available, another machine had to be brought from the warehouse; hence, the surgery was delayed for more than one hour.The patient was not injured.

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of the product and no issue was observed.Complaint of system error was confirmed.Product failed functional testing with a system error and transducer failure.Cause of errors is a transducer unplugged form a header on the main pcb.Product passed functional testing with the transducer reseated in header.The complaint was confirmed and the root cause has been determined to be an unplugged transducer.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.

• Brand Name: CONTROL UNIT DYONICS 25
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8913224
• MDR Text Key: 155042306
• Report Number: 1643264-2019-00552
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K171794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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 Catalogue Number: 7211010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1