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

Model Number	72200425
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1219602-2021-01279
• Device Sequence Number: 4395312
• Product Code: NBH
• UDI-Device Identifier: 03596010597021
• UDI-Public: 03596010597021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown