MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4 WAY FOOT PEDAL FOR FMS DUO+; FOOT-SWITCH, ELECTRICAL

Model Number	284176
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.Investigation summary = > the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: ¿ functional : intermittent operation.Per service reports, this complaint can be confirmed.The device was scrapped as system is non-repairable.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Device history review = > manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
Event or Problem Description
It was reported by the affiliate in italy that preoperatively to an unknown procedure on an unknown date, it was observed that the 4 way foot pedal for fms duo+ device was broken.During in-house engineering evaluation, it was determined that the device had an intermittent operation.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 4 WAY FOOT PEDAL FOR FMS DUO+
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16513197
• Report Number: 1221934-2023-01121
• Device Sequence Number: 6296764
• Product Code: HRX
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K954465
• 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,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 284176
• Device Catalogue Number: 284176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown