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

Catalog Number	227305
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the vapr 3.5mm hook 1-piece electrode device was broken (2+ pieces) : device fractured.It was initially reported that during an arthroscopic reconstruction of ankle ligament surgery, the device failed to function.There were no delays in the surgical procedure.It was reported that a spare device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.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: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition.The electrode's tip was found broken at the distal end and the broken fragment was not returned for evaluation.The device will be sent to the manufacturer for further review.The supplier performed an evaluation with the following results: only the device was received.The tip was broken and the fragment did not return.The handle, cable and plug assembly were in good condition with no misuse.It was confirmed that there were no ncrs or deviances recorded during the manufacturing process.The complaint reported that ¿during the surgery, the device could not work.¿ the device passed both, electrical and functional tests.The customer fault regarding device could not work couldn't be replicated.Since this was not accomplished, the complaint cannot be substantiated.The device was returned without the hook tip - breakages of this nature were investigated in a capa, and the lot number of the device is pre-corrective actions but isn't relevant to the scope of this specific complaint report.The capa concluded that controls on hook tip inspection and what tips were deemed acceptable or not acceptable were insufficient and were updated as corrective actions with retraining provided to operators.This capa is currently in verification of effectivity stage.The overall complaint was not confirmed as the observed condition of vapr 3.5mm hook 1-piece electrode -ea would have not contributed to the complained issue.Based on the investigation findings, the potential cause for the broken tip is undetermined.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 (u2503001), and no non-conformances were 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 ; 9083863534
• MDR Report Key: 25377189
• Report Number: 1221934-2026-02384
• Device Sequence Number: 10610035
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718(10)U2503001(17)280302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082643
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 227305
• Device Lot Number: U2503001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown