MAUDE Adverse Event Report: DEPUY MITEK LLC US DISP PATIENT SET FMS 24PK; ARTHROSCOPE

Catalog Number	284610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
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 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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the date of manufacture was not provided.D10: concomitant devices: 2 inflow tubing fms vue devices, therapy date: 10/16/2023.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate in japan that during an unspecified surgical procedure on (b)(6) 2023 three disp patient sets inflow tubes split when attached.However, when the first inflow tube split, water got into the main body, and the main body became out of work.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 3 for (b)(4).
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 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.The complaint device is not being returned, it was discarded by the customer.Therefore, unavailable for a physical evaluation.Since, the complaint device was discarded.We cannot determine, a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed, for the finished device and no non-conformances related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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: DISP PATIENT SET FMS 24PK
• Common Device Name: 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: 18012249
• Report Number: 1221934-2023-03913
• Device Sequence Number: 20679781
• Product Code: HRX
• UDI-Device Identifier: 10886705023226
• UDI-Public: 10886705023226
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 05/30/2024
• Device Catalogue Number: 284610
• Device Lot Number: 3004576
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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