MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CANN 7MM/76MM LTX FREE (10) GREEN; ACCESSORIES,ARTHROSCOPIC

Model Number	012421
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during surgery, their s&n cannula trocars did not seem to fit inside the cannula.They felt as if the cannula was not wide enough for the trocar and pieces broke off in the joint when inserting the trocar in the cannula.It is unknown whether there was a back up available or delay in the case.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during an arthroscopy, the s&n cannula trocar did not seem to fit inside the cannula.They felt as if the cannula was not wide enough for the trocar and pieces broke off in the joint when inserting the trocar in the cannula.The procedure was completed with the same device with no delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information: h6: health effect - impact code.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.The instructions for use were 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 review of the device specifications found that the product dimensions and tolerances are listed.A material certificate of compliance is required for each lot.A clinical review states that per the product history review, ¿confirmed no abnormalities were reported on this device during manufacture.¿ as of the date of this medical investigation, the requested clinical documentation including the operative report has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Per case details, the procedure was completed using the same device without a procedural delay.It is unknown whether the broken pieces were retained/recovered from the patient¿s joint.The cannulas are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Consequently, we are unable to make any conclusions on the impact of the possibly retained non-implantable foreign body.However, if it was retained inside of the patient¿s body, the potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNIV CANN 7MM/76MM LTX FREE (10) GREEN
• 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: 11029667
• Report Number: 1219602-2020-02076
• Device Sequence Number: 1087977
• Product Code: NBH
• UDI-Device Identifier: 03596010073655
• UDI-Public: 03596010073655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 012421
• Device Catalogue Number: 012421
• Device Lot Number: 50722915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 01/02/2023
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/20/2021; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown