MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED; ARTHROSCOPIC DRAINAGE CANNULA

Model Number	214120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by a healthcare professional in brazil that during an unknown orthopedic procedure on (b)(6) 2022, it was observed that the clear cannula system 8.5 x 75 mm ¿ threaded device was leaking and broken.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the photo does not provide enough evidence to determine root cause, the photo only shows the device inside of a plastic bag.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device lot number: 2109021, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, and considering that the device was not tested, this complaint cannot be confirmed.The device is required for testing, the photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the required evidence to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial mewatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received and evaluated.Upon visual inspection, it could be observed that the cannula is showing the silicone bung damaged.A manufacturing record evaluation was performed for the finished device lot number: 2109021, and no nonconformance's were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for reported failure can be attributed to procedural variables, such handling of the device or product interaction during procedure; excessive force being applied to pass instruments through the cannula which would cause damage to the silicone bung; as per ifu: care should be exercised to avoid puncturing the rubber seals when inserting the obturator or any other instrument through the dam.If the seals become damaged, discontinue use of the cannula.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED
• Common Device Name: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15294117
• Report Number: 1221934-2022-02558
• Device Sequence Number: 6304567
• Product Code: GEA
• UDI-Device Identifier: 10886705003617
• UDI-Public: 10886705003617
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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: 09/30/2026
• Device Model Number: 214120
• Device Catalogue Number: 214120
• Device Lot Number: 2109021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/04/2022; 04/18/2023; 04/24/2023
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/06/2022; 04/19/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2022
• 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