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

Catalog Number 7211010

Device Problems Increase in Pressure (1491); Appropriate Term/Code Not Available (3191)

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

Event Date 12/27/2018

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure, the device was over pressurizing.A backup device was available to complete the procedure with no significant delay and no patient injuries.Patient outcome is good.

Manufacturer Narrative

The device 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 no issue was observed.Complaint of over pressurization could not be reproduced.Product passed functional testing per factory test with no faults or errors.Product passed functional testing during 6 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.At no time during functional testing did pump over pressurize, fluctuate, or become intermittent.All functions perform as expected.Pressure and flow readings were normal throughout burn-in on wet station.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.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
• 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: 8206042
• MDR Text Key: 131763493
• Report Number: 1643264-2018-01014
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1