MAUDE Adverse Event Report: 4176 FOOT PED BOARD 4WAY; FOOT-SWITCH, ELECTRICAL

Model Number	284176
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary : the complaint device was received at the service center and evaluated.It was reported that ¿the activation of certain pedals no longer works¿.Per service reports, this complaint cannot be confirmed.During the service evaluation the following defects were identified: "forward" & "reverse" (black), "cannula suction" (blue) and "lavage" (red) covers deteriorate.Pedal mechanisms broken.Sub'd cover oxidized.The "forward" & "reverse" (black), "cannula suction" (blue) and "lavage" (red) covers and sub'd cover were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.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.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.
Event or Problem Description
It was reported by the customer in (b)(6) that the 4176 foot ped board 4way device was not working.During in-house engineering evaluation, it was determined that the pedal mechanisms were broken.There was no procedure nor patient involvement 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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.

• Brand Name: 4176 FOOT PED BOARD 4WAY
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• MDR Report Key: 12688674
• Report Number: 1221934-2021-03109
• Device Sequence Number: 14485032
• Product Code: HRX
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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 Model Number: 284176
• Device Catalogue Number: 284176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1