MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA SMOOTH FLEX 5.5 X 55MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200431

Device Problem Difficult to Insert (1316)

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

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, during an arthroscopy procedure, it was hard to insert the obturator to the sheath.The procedure was successfully completed with a competitor device.There was a delay of less than or equal to 30 minutes.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records could not be performed due to insufficient information but there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The cannula and two obturators were returned.All seals are in place and whole.The distal end of the cannula shaft is bent.A functional evaluation of the device found the obturator could not slide freely into the cannula.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an inadvertent impact event inconsistent with normal use, or exposure of the device to high temperatures during transport or storage.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.No containment or corrective actions are recommended at this time.

• Brand Name: CANNULA SMOOTH FLEX 5.5 X 55MM
• 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: 10972220
• MDR Text Key: 220424460
• Report Number: 1219602-2020-02009
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010597083
• UDI-Public: 03596010597083
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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: 72200431
• Device Catalogue Number: 72200431
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other