MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227305
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure aimed at treating the ¿mpfl,¿ the tip of the vapr 3.5mm hook 1-piece electrode device was found to be damaged.It was reported that the nurse noticed an abnormality with the device when they opened it and were preparing to hand it over to a scrub nurse.There was thirty-minute delay to the surgical procedure.A spare device was used to complete the surgery successfully.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 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.Device was used for treatment, not diagnosis.H11: additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional 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.Device was used for treatment, not diagnosis.H11: additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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.Device was used for treatment, not diagnosis.H11: additional narrative: investigation summary- the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it was returned in original sealed package.The tip was broken at the proximal end.The device will be send to the manufacturer for further testing.The manufacturer performed an investigation of the device returned with the following results: the device was received in the original packaging, the active tip was snapped of (visible without the blister being opened), active tip was embedded in blister, scuff marks were visible in the blister near the active tip.The device arrived in unused condition.No electrical or functional testing was performed as the device arrived in unused condition.The customer stated that they ¿noticed an abnormality regarding the device when he/she opened the device.¿ the device as presented has a visibly snapped active tip and is an unused device.The tip is embedded in the blister.The complaint can be substantiated.The complaint device has been returned for investigation.While the complaint has been classified as ¿undetermined¿, this is due to further investigation being required to determine the root cause of the complaint.A capa has been raised to investigate and determine a root cause for this issue.No functional or electrical checks have been conducted for this complaint investigation as the report is alluding to damage to the device.The failure mode has been reviewed against the systems risk assessment document."loss or deterioration of function" leading to "inside the package, system units fail to withstand transportation \ handling \ impact forces related to movement, installation or use, resulting in damage." resulting in "procedural delay" most closely correlates to the failure mode seen, with a severity of "minor" and occurrence level of "frequent" - >10^(-3).That gives a risk level of 10 and rated as 'as low as reasonably achievably (alra)'.On review of complaint log, this is the first complaint of this nature on this product.There have been (b)(4) sales of device 779300 one piece hook electrode in the period of september 2024 ¿ august 2025.According to ra, this occurrence is as expected and within alra.The overall complaint was confirmed as the observed condition of the vapr 3.5mm hook 1-piece electrode -ea would have contributed to the complained device issue.Based on the investigation findings, a product issue was identified during the investigation of the sample received and attributed to undetermined cause.The 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.Device history review- a manufacturing record evaluation was performed for the finished device u2309041, and no non-conformances were identified.

• Brand Name: VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22522424
• Report Number: 1221934-2025-02616
• Device Sequence Number: 8551279
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718(10)U2309041(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082643
• 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
• Report Date (Section B): 07/16/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 227305
• Device Lot Number: U2309041
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/05/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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