MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 8.0 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200425

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that during set up or inspection for an arthroscopy, nurse found a hair in an unopened cannula package.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of the part drawing found that packages must be free of debris, hair, etc.Greater than a specified size.The product is shipped to to be sterilized by gamma irradiation.A review of the customer provided image found a material that appears to be hair in the packaging.A circle has been drawn around the material.A visual inspection of the returned device found that the device is still in it's sealed pouch.There is no sign of physical damage to the device.A foreign matter that appears to be hair can be seen through the clear packaging.The complaint was confirmed, and the root cause has been associated with manufacturing.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.

• Brand Name: CANNULA THREADED FLEX 8.0 X 72MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11923892
• MDR Text Key: 255728837
• Report Number: 1219602-2021-01279
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010597021
• UDI-Public: 03596010597021
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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 Expiration Date: 07/09/2023
• Device Model Number: 72200425
• Device Catalogue Number: 72200425
• Device Lot Number: 425200709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1