MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS; ARTHROSCOPE

Catalog Number	284508
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure that the inflow tubing fms vue device 5 minutes after the start of the surgery, a water leak was discovered from the fms inflow section.Upon removing the inflow tube cover, a crack was found in the tube.The irrigation water was stopped, the inflow tube was removed and replaced with a new one.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.E1: the reporter¿s complete facility address was not provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: it was reported that during an arthroscopic rotator cuff repair procedure, approximately 5 minutes after the start of the surgery, a water leak was discovered from the fms inflow section.Upon removing the inflow tube cover, a crack was found in the inflow tubing fms device.The irrigation water was stopped, the inflow tube was removed and replaced with a new one.The surrounding wet areas were wiped with gauze to remove moisture, the tube was set up according to the procedure, and the run button was pressed again.Water began to flow, but the low pressure indicator flashed on the fms vue ii pump-shaver box device without detecting pressure.The tube was reattached, and the joints of each tube and the fms connection points were checked.The power was turned off the fms, the tubing was replaced again with a new one, set up according to the procedure, and reattached.It then operated normally.The initial fms setup was performed by the circulating nurse before entering the room, and it was confirmed that there was no damage to the tube.There was no surgical delay and no harm to the patient.No further information is available.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (3011614), and there was a non-conformance unrelated to the reported complaint.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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.A manufacturing record evaluation was performed for the finished device lot number, and there was a non-conformance unrelated to the reported complaint.

• Brand Name: FMS
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24690688
• Report Number: 1221934-2026-01231
• Device Sequence Number: 21259203
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: (01)10886705023066(10)3011614(17)260530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Catalogue Number: 284508
• Device Lot Number: 3011614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown