MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HD VAS 2.7 X 30 DEG SHORT NON-A/C; ARTHROSCOPE

Model Number	4131
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection the scope lens were broken in couple of pieces.Backup device available.No delay or other 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
H10: h2, h3, h4: the device, which was not used during the procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have deep distal tip and fiber damage and a bent and dented outertube.The root cause is contact with another source.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.No manufacturing related defects were observed.

• Brand Name: HD VAS 2.7 X 30 DEG SHORT NON-A/C
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10212371
• Report Number: 3003604053-2020-00056
• Device Sequence Number: 2404760
• Product Code: HRX
• UDI-Device Identifier: 03596010122322
• UDI-Public: 03596010122322
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K971253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 4131
• Device Catalogue Number: 4131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1