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 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that during a rotator cuff repair the vapr vue wireless footswitch would not pair.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the transmitter pcb was defective and minor scratches were identified with the device upon decontamination.Further, unit was heavily corroded, base plate was rusty, and inserts on the housing of the unit were broken.The repair of the device would require replacement of the housing and transmitter pcb.Since the housing cannot be replaced this unit is deemed unrepairable and it is being placed into long term hold.Fluid ingress into the unit and contact with the base plate is responsible for the corrosion.User mishandling might be the most probable root cause for the broken inserts on the housing and minor scratches on the device.The faulty parts were identified as the root cause for the reported failure during the service evaluation as the defective transmitter pcb have caused the customer to experience the footswitch to not to pair with the controller.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 rotator cuff repair the footswitch device would not pair.During in-house engineering evaluation, it was determined that the base plate was rusty, and inserts on the housing of the unit were broken on the device.It was further determined that the device was heavily corroded.Another like device was used to complete the procedure.There were no patient consequences or surgical delay 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: 11620579
• MDR Text Key: 243995867
• Report Number: 1221934-2021-01110
• 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: 04/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 227214
• Device Catalogue Number: 227214
• Device Lot Number: 1012065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1