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

Model Number	284176
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not work.Per operational and diagnostics, this complaint can be confirmed.During evaluation, it was found that the connector/pug was broken.The device was not repaired; therefore, it was not restored to the specifications.A replacement device was provided to the customer.The broken connector/pug is identified as the root cause of the reported problem.With the available information, we cannot determine how it was broken.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances 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.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate that the 4176 foot ped board 4way does not work.There were no consequence for the patient.The customer states that they have no further information.

• Brand Name: 4176 FOOT PED BOARD 4WAY
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10448436
• Report Number: 1221934-2020-02295
• Device Sequence Number: 17214382
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 07/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1