MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE 90 ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227204
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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.H11 additional narrative: the product has not returned to depuy synthes, however a photo was provided for evaluation.¿ visual inspection of the returned photo found the electrode tip side with a stain.The overall complaint was confirmed as the observed condition of the vapr premiere 90 electrode -ea 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.
Event or Problem Description
It was reported that during a rotator cuff repair surgery, the 5.5 healix advance br w/ocord anchor device was broken off.It was reported that all broken parts were removed.Another device was used to complete the surgery.Additionally, it was reported that there was foreign matter observed on the vapr premiere 90 electrode device.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.Report 1 of 2 for (b)(4).
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: additional information was received from the reporter which stated: foreign bodies are colloidal substances that adhere to the radiofrequency blade.
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 actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.
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 was returned to depuy synthes for evaluation.Visual inspection of the returned device found the device returned in the original packing and without signs of use.The active tip had foreign matter at the proximal end.The shaft, cord and handle did not show any signs of damage.The device will be sent to the manufacturer for further testing.A visual inspection of the device was performed by the manufacturer; as a result, device was received in its original packaging, the active tip was used, tissue debris inside of the active tip, rust on the active tip.A small sample of unidentified foreign matter was received within the packaging wrap.The device passed all electrical and functional checks.There was evidence of rust on the active tip and there was also a piece of fibre in the sterilization bag the device was returned in, but is not certain if this was the foreign matter detailed in the original customer issue.The complaint device has been returned to for investigation.The device returned corresponds to the device in the report that presented foreign matter.Visual inspection shows the electrode tip is discolored, but the appearance is as expected post activation, no visual abnormalities or anomalies were detected.This discoloration would have been caused by the functional testing of the product in saline during the manufacturing process and previously investigated under capa.The functional testing of devices in saline has been confirmed as the assignable root cause of the discoloration.A saline management system was implemented in aug 2021 to help reduce this type of discoloration on the surface of the electrode tip, as it has been shown that by controlling the saline conditions the discoloration can be reduced, however it cannot be eliminated under current process controls as the devices continue to be 100% functionally tested in saline.The overall complaint was confirmed as the observed condition of the vapr premiere 90 electrode -ea would have contributed to the complained device issue.¿ a manufacturing record evaluation was performed for the finished device u2502007, and no non-conformances were identified.Based on the investigation findings, the potential cause for the reported condition could be traced to the manufacturing process.This product issue has been addressed through supplier quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: VAPR PREMIERE 90 ELECTRODE -EA
• 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: 23806048
• Report Number: 1221934-2025-04771
• Device Sequence Number: 13108796
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2502007(17)280224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 227204
• Device Lot Number: U2502007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/28/2025; 01/05/2026; 02/24/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/06/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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