MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FMS VUE II PUMP-SHAVER BOX; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284004

Device Problems Moisture Damage (1405); Overfill (2404); Output Problem (3005)

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).Initial reporter occupation: reporter is a j&j employee.Device manufacture date: the device manufacture date is currently unavailable.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 2 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 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 lit 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 device was 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 customer provided a photo of the pump, the image shows the front side and controls of the pump, the pump is not turned on and it is not set up with the tubbing.The complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: ¿functional : electrical/electronic component failure.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.A manufacturing record evaluation was performed for the finished device j10a70319, and no non-conformances were identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts were identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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.

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 received at the service center and evaluated.During the service evaluation the following defects were identified: functional : electrical/electronic component failure.Per service reports, this complaint can be confirmed.The circuit board, power supply were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: FMS VUE II PUMP-SHAVER BOX
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15242967
• MDR Text Key: 305465677
• Report Number: 1221934-2022-02536
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705027934
• UDI-Public: 10886705027934
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171237
• 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

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: 284004
• Device Catalogue Number: 284004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1