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

Catalog Number	7211010F
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during elbow arthroscopy, dyonic 25 was overheating.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional 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 no issue was observed.Complaint of overheating could not be confirmed.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 overheating occurred during functional testing and burn-in.All functions perform as expected.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.A complaint history review found no related failures.No containment or corrective actions are recommended at this time.

• Brand Name: RFB CONTROL UNIT DYONICS 25
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9490215
• Report Number: 1643264-2019-00888
• Device Sequence Number: 13756857
• Product Code: HRX
• UDI-Device Identifier: 03596010643827
• UDI-Public: 03596010643827
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7211010F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1