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

Model Number 72202959S

Device Problem Crack (1135)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

It was reported that during procedure, the scope got cracked on the outside lens.No delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.Internal complaint reference (b)(4).H3, h6: the reported device, used in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A visual inspection revealed distal tip/fiber damage, cracked negative lens, and broken lenses.The complaint was confirmed.Factors that could have contributed to the reported event an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: VAS HD AC 4MM X 30 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10756129
• MDR Text Key: 213700418
• Report Number: 3003604053-2020-00139
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885554023367
• UDI-Public: 00885554023367
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 72202959S
• Device Catalogue Number: 72202959S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1