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

Model Number 72200829

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported that, during surgery, at the moment the "6mm high flow cannula" was inserted in the point, the surgical staff realized that the metal part in the cannula was through the coagulation.They identified that was loose.The procedure was completed without delay using a back-up device.No additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.The cann h.F.Dgnst 6mm rtbl dbl vlv instructions for use warns, ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ a review of the cann h.F.Dgnst 6mm rtbl dbl vlv risk management files was performed and found multiple line items addressing this failure mode.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).

• 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: 10737739
• MDR Text Key: 213162080
• Report Number: 1219602-2020-01660
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 72200829
• Device Catalogue Number: 72200829
• Device Lot Number: 50557876
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention