MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED DISP 8.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72200903
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a shoulder surgery, a small piece of plastic rubber of the threaded cannula broke into the joint.All pieces were removed by tissue grasper.The procedure was completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used 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 a repeat issue.A review of device records showed 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 review of risk management files found that the reported failure was documented appropriately.A visual inspection found that the rubber seal on the top of the cap has been damaged and is missing a small piece of rubber.The piece of missing rubber was found in the inside of the cap.Both caps are are are scratched and have missing and damaged tabs.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include excessive force, off-axis insertion of sharp instruments, or fatigue on the seal from insertion and removal.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 THREADED DISP 8.5 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11757697
• Report Number: 1219602-2021-01007
• Device Sequence Number: 3439084
• Product Code: NBH
• UDI-Device Identifier: 03596010595119
• UDI-Public: 03596010595119
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/25/2022
• Device Model Number: 72200903
• Device Catalogue Number: 72200903
• Device Lot Number: 903191225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention