MAUDE Adverse Event Report: DEPUY MITEK LLC US FOOT PEDAL(FMS VUE/NEXTRA); FOOT-SWITCH, ELECTRICAL

Catalog Number 283573

Device Problem Failure to Read Input Signal (1581)

Patient Problem Not Applicable (3189)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the sales rep via phone that during a knee arthroscopy the customer's fms 5 way foot pedal lavage button worked intermittently.The case was completed with another like-device with no patient harm, but a two minute delay to obtain a new device.The sales rep was not present and could not provide further information.The device is being returned.

Manufacturer Narrative

Product complaint # (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary
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> the complaint device was received and evaluated.Visual observation reveals that the device is in worn condition.The device was connected to a fms duo pump and tested with a handpiece, none of the functions of the device worked as intended.The complaint of intermittent operation can be confirmed.Although a specific root cause could not be discerned at this point, the age of the device and the worn condition possibly attribute to the failure of the device since the device is approximately 4 years old.A manufacturing record evaluation was performed for the finished device serial number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.The device will be stored in a secured area.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.Udi:(b)(4).

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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: serial number: the serial number was documented as (b)(4).On the initial report and has been updated as (b)(4).Therefore, udi: udi: (b)(4).Additional information: investigation summary: the received device serial number does not match with the one on the complaint.The device looked worn.The fms duo keeps beeping when trying to connect the device.None of the functions work, the device was not being recognized.The complaint device was received and evaluated.A manufacturing record evaluation was performed for the finished device serial number, and no non-conformances were identified.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.

• Brand Name: FOOT PEDAL(FMS VUE/NEXTRA)
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8484506
• MDR Text Key: 141191789
• Report Number: 1221934-2019-56767
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705017010
• UDI-Public: 10886705017010
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 05/09/2019
• Patient Sequence Number: 1