MAUDE Adverse Event Report: DEPUY MITEK LLC US IRRIGATION TUBESET 24PK; ARTHROSCOPE

Catalog Number 284504

Device Problem Overfill (2404)

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

Event Date 01/01/2023

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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: d10.Concomitant med products: fms duo pump e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi:(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep in israel that during a shoulder arthroscopy surgical procedure on an unknown date, while using an fms duo pump device, the saline chamber filled all way up two different sets of inflow tubing.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for the same event in (b)(4).

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.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.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The complaint device was received and evaluated.Upon visual inspection it could be observed that the device does not show structural anomalies.However the tube that goes connected to the pump sensor had residues of saline water.To test its functionality the device was connected to a test fms duo pump, the fill chamber function was activated and the fill chamber was filled without anomalies.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the saline water residues found in the tube that goes connected to the pump sensor which is consistent that the all expansion chamber was filled to the top, this complaint was 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 installing the tubing set; the blue connector that goes to the pump sensor could not have been properly connected; the blue connector was not turned clockwise as far as it would go, causing air pressure to escape from the tube and consequently causing the expansion chamber to fill completely.However, this cannot be conclusively determined.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: IRRIGATION TUBESET 24PK
• Type of Device: 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: 18093492
• MDR Text Key: 327765774
• Report Number: 1221934-2023-04063
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705017393
• UDI-Public: 10886705017393
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284504
• Device Lot Number: 3005468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1