MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFURB, 3RD ED., C/U, S&N DYONICS 25; ARTHROSCOPE

Catalog Number 7211010F3E

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the refurb 3rd ed.C/u s&n dyonics 25 pump was running over.This occurred during the procedure.A backup device was not used to complete the procedure.There were no delays or patient injuries reported.

Manufacturer Narrative

Device investigation narrative - complaint of pressure malfunction could not be reproduced.Product passed functional testing with no faults or errors.Product passed functional testing during 4 hour burn-in on wet station utilizing low and high pressure and flow settings.Raw and zero transducer readings were normal and well within specs during all functional tests.No over pressurization or errors occurred during functional testing or burn-in.Please refer to the operations/service manual (part number 1061600) for troubleshooting guidance if poor or erratic pressure performance is observed.A review of the service device history record shows that this unit passed all acceptance criteria and was compliant upon release for distribution on or about october 10, 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.

• Brand Name: REFURB, 3RD ED., C/U, S&N DYONICS 25
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6207065
• MDR Text Key: 63639561
• Report Number: 1643264-2016-00311
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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: 7211010F3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR