MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN H.F. DGNST 6MM RTBL DBL VLV; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72200829
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a meniscal repair surgery, once patient was anesthetized and the procedure began the surgical support connected the cables to the tower and realized that the lens was missing, the surgical support went to the central sterilization where it was found that the lens was in one of the unsterilized containers.The specialist decided to cancel the procedure.The patient's anesthesia was reversed.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information in b5.
Event or Problem Description
It was reported that during a meniscal repair surgery, once patient was anesthetized and the procedure began the surgical support connected the cables to the tower and realized that the cannula was not in the operation room, the surgical support went to the central sterilization where it was found that the cannula was in one of the unsterilized containers.The specialist decided to cancel the procedure.The patient's anesthesia was reversed.No further complications were reported.
Additional Manufacturer Narrative
H6: a device evaluation was not possible, since the device was not returned to the designated complaint unit for independent evaluation.The root cause of the reported event could not be determined as no device malfunction was reported.An evaluation of the customer provided image found the device laying on a tray.There is no visible damage.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification 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.Based on the information provided we are unable to conclude factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: a device evaluation was not possible, since the device was not returned to the designated complaint unit for independent evaluation.The root cause of the reported event could not be determined as no device malfunction was reported.An evaluation of the customer provided image found the device laying on a tray.There is no visible damage.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification 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.Based on the information provided we are unable to conclude factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: CANN H.F. DGNST 6MM RTBL DBL VLV
• 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: 19924209
• Report Number: 1219602-2024-01666
• Device Sequence Number: 15479772
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: 03596010573520
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/07/2025

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 Catalogue Number: 72200829
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 12/27/2024; 01/03/2025
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/06/2024; 12/31/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male