MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE); SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problems Leak/Splash (1354); Overfill (2404)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

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.Udi #: (b)(4).Reporter is a j&j employee.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 Description

This is report 1 of 3 for (b)(4).It was reported by the affiliate in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2022, it was observed that the the fluid volume in the chamber of the inflow tubing (284508) device kept increasing up over the maximum level.According to the report, the filter allowed fluid to pass through easily and directly into the pressure sensor connect port on the fms main unit (284004).It was reported that as the fluid had entered the inside of the fms device, a warning lighted up on the display.It was reported that a new inflow tubing was replaced, which did not correct the issue either.It was reported that once they turned it off, it wouldn't turn on.It was reported that there was no response even after changing the power cord and changing the insertion point.It was reported that it was confirmed that the fuse inside was blown.It was reported that after replacing the fuse, it started but did not work properly.As a result, the shaver (283512) became unusable.Another like devices were used to complete the procedure with less than 30 minutes delay.There was no harm to the patient.No additional information was provided.

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 tubing is shown along with the expansion chamber, on a closed view, the pressure sensor filter shows saline fluid infiltration due to fill chamber overfilling.A manufacturing record evaluation was performed for the finished device 3002317 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the photo inspection result, this complaint can be confirmed.A possible root cause can be attributed to the procedural variables, such handling of the device or product interaction during the set up and preparation of the pump; when the tubing was connected into pump's pressure sensor, the pump's connector lock pin was not firmly pushed with the tubbing, therefore, the connector did not closed well and the pressure sensor did not detect the fluid level, overfilling the expansion chamber, when overfilling occurs, the fluid can get inside the pressure sensor and damage the pump, as per ifu: make sure the quick connect port is open before inserting the quick connect tube.To open, press down on the lever at the top of the port.Connect the pressure sensor quick connect tube to the fill chamber port on the fms vue ii pump.The connector clicks when it is locked.Over-filling the chamber may wet the pressure sensor filter, which may interfere with accurate pressure measurement.The fill chamber mark indicates correct fluid level.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.

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 was returned and evaluated.Upon visual inspection, the tubing in general has no structural anomalies as well as the expansion chamber.The pressure sensor filter shows saline fluid infiltration due to fill chamber overfilling.A manufacturing record evaluation was performed for the finished device 3002317 number, and no non-conformances 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.A possible root cause can be attributed to the procedural variables, such handling of the device or product interaction during the set up and preparation of the pump; when the tubing was connected into pump's pressure sensor, the pump's connector lock pin was not firmly pushed with the tubbing, therefore, the connector did not closed well and the pressure sensor did not detect the fluid level overfilling the expansion chamber, when overfilling occurs, the fluid can get inside the pressure sensor and damage the pump, as per fms vue ii operator's manual 115810; make sure the quick connect port is open before inserting the quick connect tube.To open, press down on the lever at the top of the port.Connect the pressure sensor quick connect tube to the fill chamber port on the fms vue ii pump.The connector clicks when it is locked.Over-filling the chamber may wet the pressure sensor filter, which may interfere with accurate pressure measurement.The fill chamber mark indicates correct fluid level.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.

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.

• Brand Name: FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE)
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• 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: 15243039
• MDR Text Key: 305370930
• Report Number: 1221934-2022-02535
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• 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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 3002317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/18/2022; 10/19/2022; 10/28/2022
• Supplement Dates FDA Received: 09/19/2022; 10/20/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1