MAUDE Adverse Event Report: DEPUY MITEK LLC US IRRIGATION TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number	284504
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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 or Problem Description
It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6)2021, it was observed that the chamber on the pump started to fill up and a high pressure code was displayed.It was reported that a lot of solution was squirting out from the joint.According to the report, after replacing the fms fluid management system/inflow tubing (fms duo+ or fms solo) the error code was cleared and the issue of the chamber got solved.The procedure was completed with a delay of less than five minutes.There were no adverse no patient consequences reported.No additional information was provided.
Additional 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.Investigation summary: according to the information provided, it was reported that during a rotator cuff repair the chamber of the pump started to fill up and a high pressure code was displayed.A lot of solution was squirting out from the joint.After replacing the fms fluid management system/inflow tubing (fms duo+ or fms solo) the error code was cleared and the issue of the chamber got solved.The complaint device was received and evaluated.Upon visual inspection, the tubbing has no structural anomalies, holes, scratches or obstructions.The tubbing was tested on an fms duo+ test pump.When starting the pump, the fill chamber was filled on the min/max mark, the fill chamber did not overfill.The pressure on the pump was increased from 20 to 70 and the chamber did not overfill, and no error code appeared.A manufacturing record evaluation was performed for the finished device 3000883 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 and the functional test result, this complaint cannot be confirmed.The root cause for the reported issue can be attributed to procedural variables, such handling of the device or product interaction during procedure.The white clamp that is located below chamber may have been closed or the tubbing was bent, 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.Device history lot : an mre review was performed and results obtained as below : product code : 284504.Lot number : 3000883.Anomalies or discrepancies (non-conformance) : none.
Additional 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.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: IRRIGATION TUBESET 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12233857
• Report Number: 1221934-2021-02304
• Device Sequence Number: 14726727
• Product Code: HRX
• UDI-Device Identifier: 10886705017393
• UDI-Public: 10886705017393
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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: 10/30/2022
• Device Model Number: 284504
• Device Catalogue Number: 284504
• Device Lot Number: 3000883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 08/24/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1