MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3); ARTHROSCOPE

Model Number	7211006
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inflow/outflow fork suction the transducer membranes were missing.The incident occurred before the procedure; no delay, backup device available.No complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the reported device was received for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation did not reveal any problems.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the reported event, include an improper or loose connection to the concomitant device.A review of the device history record shows there are 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 concluded this was a repeat issue.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10495023
• Report Number: 1643264-2020-01051
• Device Sequence Number: 19503043
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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 Model Number: 7211006
• Device Catalogue Number: 7211006
• Device Lot Number: 50858883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1