MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN H.F. DGNST 6MM RTBL DBL VLV; ACCESSORIES,ARTHROSCOPIC

Model Number 72200829

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that the cannula was rusty.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.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 other related failures.Factors that are known to contribute to the alleged fault/failure may include shipping damage, a component failure, or handling.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.

• Brand Name: CANN H.F. DGNST 6MM RTBL DBL VLV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10457178
• MDR Text Key: 204534969
• Report Number: 1219602-2020-01321
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: 03596010573520
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 72200829
• Device Catalogue Number: 72200829
• Device Lot Number: 333839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1