MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH, DYONICS POWER II; ARTHROSCOPE

Model Number 72201092

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, when the footswitch was plugged in, the shaver operated irrespective of the pedals being pressed.The procedure was completed without surgical delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection was performed and no deficiencies were observed.The reported malfunction was not observed during functional evaluation.There was no relationship found between the device and the reported event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include a failure of a concomitant device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTSWITCH, DYONICS POWER II
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15397977
• MDR Text Key: 304913808
• Report Number: 1643264-2022-00329
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607423
• UDI-Public: 03596010607423
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201092
• Device Catalogue Number: 72201092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• 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