MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS HD AC 4MM X 30 DEG; ARTHROSCOPE

Model Number	72202959S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy procedure, the distal end of the lens was found cracked outside the patient.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, which was used in a 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 distal tip and fiber damage, a dented outertube and distal lens damage.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• Brand Name: VAS HD AC 4MM X 30 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10610109
• Report Number: 3003604053-2020-00114
• Device Sequence Number: 1281925
• Product Code: HRX
• UDI-Device Identifier: 00885554023367
• UDI-Public: 00885554023367
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• 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): 10/15/2020

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: 72202959S
• Device Catalogue Number: 72202959S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1