MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP FOOTSWITCH EP-1; ARTHROSCOPE

Catalog Number	7205396
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery, the shaver keeps running.A handpiece error message did not occur.The procedure was successfully completed with a back up device, delay in the case or patient injury were not reported.Revision surgery was not performed.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and found the housing was corroded.Footswitch failed functional testing with footswitch error using a known good control unit and mdu.The left pedal failed to function properly; the actuator was stuck from corrosion buildup.The complaint was confirmed and the root cause was determined to be the corroded actuator.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: SERVICE REP FOOTSWITCH EP-1
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8220873
• Report Number: 1643264-2019-00021
• Device Sequence Number: 276671
• Product Code: HRX
• UDI-Device Identifier: 03596010251978
• UDI-Public: 03596010251978
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• 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,Followup
• Report Date (Section B): 02/27/2019

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: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 02/26/2019
• Initial Report FDA Received Date: 01/06/2019
• Supplement Report FDA Received Date: 01/08/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1