MAUDE Adverse Event Report: DEPUY MITEK LLC US REUSE PATIENT SET FMS 24PK; ARTHROSCOPE

Catalog Number	284649
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: unknown at this time udi: ((b)(4) investigation summary: the photo investigation revealed that reuse patient set fms 24pk was in the packaging tray.The device had water residues.No anomalies could be observed.The overall complaint was unconfirmed as the observed condition of the reuse patient set fms 24pk would not contribute to the complained device issue.Based on the investigation findings, the potential cause for the reported condition is traced to the procedural variables, such handling of the device or product interaction during the system set up.Multiple factors are associated with this type of failure, the complaint device needs to be physically evaluated in order to determine why the customer experienced the failure, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during an unspecified surgical procedure the reuse patient set fms device and the inflow tubing fms vue devices were being used when the two hoses did not allow the pump to work and the water was dumped or watered, which is why we had to open the other two spare hoses so that the pump could start and function correctly, which delayed the surgery for approximately 1 hour, the time in which the pump and hoses were tested until they worked correctly.The surgery was finally completed successfully but with effects on the patient since it was necessary to extend his anesthesia times.Yes, the patient was affected since it was necessary to intraoperatively extend his anesthesia times due to the delay of approximately 1 hour in surgery.No additional information was provided.This is report 1 of 2 for (b)(4).
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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: h4: added udi: (b)(4).
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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it was in used condition.Signs of saline solution could be observed on the inside of the device.No other anomalies could be observed.A functional test was performed by connecting the tubbing to a fms pump, the tubbing was set up.When activating the pump, a leak could be observed at the proximal end on the connector.The overall complaint was confirmed as the observed condition of the reuse patient set fms 24pk would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during the system set up.It is possible that the connector thread got damaged during assembly for the setup, therefore causing the leak.As per the instructions for use, to avoid damage to the tubing make sure that tubing is centered on the groove of the pump.Waste line is intended to connect to waste bag and is not approved for external suction systems.If external suction device is used, tubing may collapse.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device 3005336, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: REUSE PATIENT SET FMS 24PK
• Common Device Name: ARTHROSCOPE
• 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: 19276406
• Report Number: 1221934-2024-01537
• Device Sequence Number: 6339104
• Product Code: HRX
• UDI-Device Identifier: 10886705023233
• UDI-Public: 10886705023233
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951843
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2024

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: 08/30/2024
• Device Catalogue Number: 284649
• Device Lot Number: 3005336
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 03/25/2025; 03/31/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/12/2024; 03/25/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown