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	07/21/2020
Type of Reportable Event	Serious Injury
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 scratched and cracked 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 no related failures; this failure mode will be trended to assess for any necessary corrective actions.Factors that are known to contribute to the alleged fault/ failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.If the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.
Event or Problem Description
It was reported that, during a knee arthroscopy, the videoarthroscopic was found to have a cracked lens.There was a backup device available.No delay or patient injury was reported.Results of investigation revealed that during visual evaluation the scope distal lens was cracked, 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: 10513609
• Report Number: 3003604053-2020-00097
• Device Sequence Number: 11647359
• 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): 09/10/2020

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: 07/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/10/2020
• 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