MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 2.3MM WEDGE 1-PIECE ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 227203

Device Problems Break (1069); Display or Visual Feedback Problem (1184)

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

Event Date 02/27/2024

Event Type  malfunction  

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 additional information should become available, a supplemental medwatch will be submitted accordingly.Udi:(b)(4).Investigation summary: according to the information received, it was reported that during the surgery, when in use, noted many bubbles (as the video shows), and is was found the ceramic was broken (as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.The photos and video investigation revealed that vapr 2.3mm wedge 1-piece electrode -ea was producing bubbles when activated.The ceramic insulator is cracked.The overall complaint was confirmed as the observed condition of the vapr 2.3mm wedge 1-piece electrode -ea would contribute to the complained device issue.A manufacturing record evaluation was performed for the finished device lot number (u2302084) and no non-conformances were identified.Based on the investigation findings, the potential cause for the cracked ceramic insulator can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.The potential cause for the bubbles will be determined once the device is evaluated physically.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

Event Description

It was reported by the healthcare professional in china that during anterior/posterior repair procedure on (b)(6) 2024, when using the vapr 2.3mm wedge 1-piece electrode device many bubbles were observed and it was found that the ceramic was broken.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: VAPR 2.3MM WEDGE 1-PIECE ELECTRODE -EA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18847604
• MDR Text Key: 337211261
• Report Number: 1221934-2024-00678
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009619
• UDI-Public: 10886705009619
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227203
• Device Lot Number: U2302084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1