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

Model Number	284176
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter phone number: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email that during shoulder arthroscopy the 4176 foot ped board 4way left black pedal has dislocated from the pedal construct.The procedure was completed with same device.No patient consequences or surgical delay reported.The device was discarded and is not available to be returned for evaluation.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, our affiliate informed us that the device will be discarded, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.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.Device history lot: a review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was a possibility of a delay in surgery for two to five minutes.

• 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: 9788911
• Report Number: 1221934-2020-00749
• Device Sequence Number: 618462
• Product Code: GEI
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2020

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?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/20/2020; 03/24/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/23/2020; 03/25/2020
• Patient Sequence Number: 1