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

Model Number	72202959S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, which was used in 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 distal tip and fiber damage and a cracked and scratched distal lens.The root cause is contact with another source.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions a device labeling/ifu review was performed and indicated instructions for use includes recommendations, instructions and precautionary statements for proper use of the product.The risk level based on severity and final occurrence is acceptable.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.No manufacturing related defects were observed.
Event or Problem Description
It was reported that during knee scope procedure, the scope was scratched.A backup device was available to complete the procedure with no delay or patient injuries.Results of investigation have concluded that this unit has a cracked distal lens which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 10569711
• Report Number: 3003604053-2020-00110
• Device Sequence Number: 3167807
• Product Code: HRX
• UDI-Device Identifier: 00885554023367
• UDI-Public: 00885554023367
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention