MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA CLEARTRAC THREADED 7.0 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200905

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2019

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the cannula had small pieces of plastic.This device was used in the patient and the plastic piece fell off into the patient but it was retrieved from.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during a shoulder procedure, the cannula had small pieces of plastic.This device was used in the patient and the plastic piece fell off into the patient but it was retrieved from.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one 72200905 threaded disposable cannula product used for treatment, was returned for evaluation.This product has a j-lock channel on the cannula tube top that mates and twist locks snugly with the cannula head component.The tube top was slightly loose upon receipt.There was a small piece of foam returned.Upon opening the cannula top, the source was confirmed.The fragment came from the inner foam seal of the cannula top.The fragment was poked through and ripped off the foam seal by either pressure or use of a sharp instrument.Product met specifications upon release to distribution.

• Brand Name: CANNULA CLEARTRAC THREADED 7.0 X 72MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9734899
• MDR Text Key: 181488685
• Report Number: 1219602-2020-00273
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010595133
• UDI-Public: 03596010595133
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/19/2020

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 Expiration Date: 06/27/2022
• Device Model Number: 72200905
• Device Catalogue Number: 72200905
• Device Lot Number: 905190627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR