MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	225002
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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.Additional narrative: investigation summary = > a photo was provided for evaluation.Visual inspection of the returned photo found that one of the internal connector pin of the device was missing.No other anomalies were noted on the device.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that one of the internal connector pin of the device was missing and another one was deformed.No other anomalies were noted on the device.The overall complaint was confirmed as the observed condition of the vapr handpiece *ea would have contributed to the complained device issue.Based on the investigation findings, the potential cause for the device condition could be traced to use excessive force when inserting the electrode to the handpiece and misaligned before pushing it together.As per instructions for use (ifu), 1) connect a new electrode to the handpiece.Check that the handpiece and electrode are properly aligned before pushing together.Properly handling and attention to the approved use of the device diminishes the risk of 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 = > manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the vapr handpiece device fell apart.It was initially reported that during a rotator cuff repair procedure, it was discovered that one internal contact pin was missing.It was not reported if there were any delays to the surgical procedure or if a spare device was available for use.The exact date of the event was unknown.However, it was reported that the event occurred in 2026.All available information has been disclosed.

• 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 ; 9083863534
• MDR Report Key: 24983969
• Report Number: 1221934-2026-01661
• Device Sequence Number: 9480817
• Product Code: GEI
• UDI-Device Identifier: 10886705009053
• UDI-Public: (01)10886705009053(10)2507001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K963783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 225002
• Device Lot Number: 2507001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown