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

Model Number	72200425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unspecified surgery, the threaded cannula broke when it was being pulled out of the joint, and after breaking the product stayed in the joint.The nurse had to open another product and to go again inside the joint.It is unknown if the broken pieces were removed from the patient and if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair, the threaded cannula broke when it was being pulled out of the joint, and after breaking the product stayed in the joint.The nurse had to open another product and to go again inside the joint.No delay delay was reported.The broken pieces were removed from the patient.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Corrected information in h6 (health effect - impact code).
Event or Problem Description
It was reported that during a rotator cuff repair, the threaded cannula broke when it was being pulled out of the joint, and after breaking the product stayed in the joint.The nurse had to open another product and to go again inside the joint.The broken pieces were removed from the patient using a handheld grasper.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
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.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.Per case details, a drawing of the broken (threaded cannula) device provided per the 8/9/22 correspondence, confirmed the device breakage occurred while inside the patient.Reportedly, all the broken pieces of the device were removed from the patient with the handheld grasper, and no medical intervention was required due to the reported device failure.Reportedly, a smith and nephew back-up device was used to complete the procedure without a surgical delay.The patient¿s current health status is unknown.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 contributed to the event.The patient impact beyond the reported is not anticipated, as all broken pieced were reportedly removed from inside the patient, ¿no further complications were reported¿, and no patient injury has been alleged.Therefore, no further clinical/medical assessment can be rendered.A complaint history review found no similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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: 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: 14920502
• Report Number: 1219602-2022-00942
• Device Sequence Number: 16652034
• Product Code: NBH
• UDI-Device Identifier: 03596010597021
• UDI-Public: 03596010597021
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/01/2022

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: 04/09/2024
• Device Model Number: 72200425
• Device Catalogue Number: 72200425
• Device Lot Number: 425210409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 08/09/2022; 08/29/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/18/2022; 08/09/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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