MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/O ONE-WAY VALVE; ARTHROSCOPE

Model Number 284610

Device Problems Use of Device Problem (1670); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/24/2023

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 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.H10 additional narrative: udi: (b)(4).H4: the device manufacture date is currently unavailable.Investigation summary: both a photo and the complaint device were received and evaluated.Two photos were received and evaluated.Visual analysis of the photos revealed that in the first photo the device was shown in its packaging while in the second photo the back part of the packaging was shown.The device appeared to be in a normal condition.It was not possible to identify a damage/failure in the device with the photos provided.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The device was received whit its original packaging open, the device was in used condition, no anomalies were found in the external condition, but saline residues were found inside the tubes.To test its functionality, a test fms vue pump, test handpiece and a test blade were used, the tube was placed in the bracket of the pump, its correct position was verified, the pump was activated as well as the handpiece.The chamber was fill and the outflow system was working smoothly.A manufacturing record evaluation was performed for the finished device lot number: 3002962, and no non-conformances were identified.Based on the visual and functional inspection results, this complaint cannot be confirmed.Since the device passed the functional testing, it is not possible to determine a root cause for the issue experienced by the customer at this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthese mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported by the distributor in brazil that during an unknown procedure on (b)(6) 2023, it was observed that the fms fluid management system outflow tubing w/out one-way valve (fms vue or fms duo) device did not work.During in-house engineering evaluation, it was determined that there were saline residues were inside the tubes.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/O ONE-WAY VALVE
• 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: 17326627
• MDR Text Key: 319654542
• Report Number: 1221934-2023-02761
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023226
• UDI-Public: 10886705023226
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

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: 10/30/2023
• Device Model Number: 284610
• Device Catalogue Number: 284610
• Device Lot Number: 3002962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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