MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 6.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72200427

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, during set up for a rotator cuff repair, a piece of plastic was present in the clear-trac flexible cannula and prevented the chuck from passing through.No delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.Per the results of the investigation, the visual inspection of the returned device found that the bottom gasket of the cannula is fractured and a piece of the rubber is in the shaft of the cannula.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The bottom gasket of the cannula is fractured and a piece of the rubber is in the shaft of the cannula.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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 review of the assembly specifications found that, when visually inspected, no contamination >0.15mm² should be found.The root cause has been associated with a component failure.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

Event Description

It was reported that, during set up for a rotator cuff repair, a piece of plastic was present in the clear-trac flexible cannula and prevented the chuck from passing through.No delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.

• Brand Name: CANNULA THREADED FLEX 6.5 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: 18692140
• MDR Text Key: 335329447
• Report Number: 1219602-2024-00269
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: 03/23/2024
• Device Catalogue Number: 72200427
• Device Lot Number: 427210323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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