MAUDE Adverse Event Report: DePuy Mitek LLC US VAPR; Electrosurgical, Cutting & Coagulation & Accessories

Catalog Number	225028
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip arthroscopy procedure was performed on a patient on (b)(6)2026, using the vapr device, among other devices.The device was connected to the vapr system for the purpose of performing ablation and coagulation during the arthroscopy procedure.Approximately two weeks after the surgery, the patient arrived for a follow-up visit and complained of pain in the surgical area.Imaging examination demonstrated that a metal component had remained in the patient¿s hip.Accordingly, the surgeon scheduled an additional procedure to remove the metal component.This procedure was performed approximately two weeks later, and the metal component was removed.According to the report, the metal component had detached from the device in question.At this stage, it is not known whether the component broke or became detached.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product has not returned to depuy synthes, however photos were provided for evaluation.Visual inspection of the returned photos showed the return cap detached from the device and deformed.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the vapr tripolar 90 suction elect would have contributed to the complained device issue.Based on the investigation findings, a potential cause cannot be established.Multiple factors are associated with this type of failure, and the complaint device needs to be physically received and evaluated to determine a potential cause of why the customer experienced the failure.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 reported 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.Device history review: a manufacturing record evaluation was performed for the finished device lot number (u2510011), and no non-conformance was identified.

• Brand Name: VAPR
• Common Device Name: Electrosurgical, Cutting & Coagulation & Accessories
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50482452
• Report Number: 1221934-2026-03847
• Device Sequence Number: 16011034
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: (01)10886705023103(10)U2510011(17)281026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 225028
• Device Lot Number: U2510011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown