MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 5.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72200429
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy procedure, it was not possible to remove the obturator from the cannula.The customer removed the device, but the obturator broke in the cannula.This problem occurred outside the patient.The procedure was successfully completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The proximal end of the obturator is fractured away and was not returned, from the base of the hub on the proximal end to the distal tip is stuck, embedded in 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 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.The root cause has been 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 or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: CANNULA THREADED FLEX 5.5 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: 16247522
• Report Number: 1219602-2023-00108
• Device Sequence Number: 6406215
• Product Code: NBH
• UDI-Device Identifier: 03596010597069
• UDI-Public: 03596010597069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Model Number: 72200429
• Device Catalogue Number: 72200429
• Device Lot Number: 429220512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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
• Patient Sex: Unknown