MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH; FOOT-SWITCH, ELECTRICAL

Model Number 227214

Device Problem Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that wireless pedals loosing connection.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the transmitter pcb was defective, and footswitch failed pairing.Further, battery tray assembly was corroded, and bump on pads were missing.Additionally, minor scratches were identified with the device upon decontamination.The transmitter pcb, battery tray assembly and bump on pads were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the battery tray assembly is responsible for the corrosion.User mishandling might be the most probable root cause for the missing bump on pad and the minor scratches on device.The corroded battery tray assembly and defective transmitter pcb might be the most probable root cause for the pairing failure of the foot switch.There are no indications from this complaint investigation that the issue/ failure is manufacturing-related, therefore a manufacturing record evaluation is not required.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 Description

It was reported by the sales rep that during a shoulder procedure on (b)(6) 2021, it was observed that the foot switch device was losing connection.During in-house engineering evaluation, it was determined that the battery tray assembly was corroded.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR VUE WIRELESS FOOTSWITCH
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11716808
• MDR Text Key: 261683212
• Report Number: 1221934-2021-01299
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009657
• UDI-Public: 10886705009657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 227214
• Device Catalogue Number: 227214
• Device Lot Number: 1606138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1