MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPE ACLV 2.7X30D SHORT

Catalog Number	7205682
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device lens is not clear.No back-up available.There was not significant delay and no patient injuries.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date, the additional information received was that there was a back-up available (same device), the loss of visualization was before the device was in the patient.
Event or Problem Description
It was reported that the device lens is not clear.Loss of visualization was before the case.There was not significant delay and no patient injuries.A back-up device was able to be used.

• Brand Name: ARTHROSCOPE ACLV 2.7X30D SHORT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8078263
• Report Number: 3003604053-2018-00177
• Device Sequence Number: 11095999
• Product Code: HRX
• UDI-Device Identifier: 03596010380432
• UDI-Public: 03596010380432
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• 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): 11/19/2018

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: 7205682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1