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	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
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.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a rotator cuff repair procedure it was observed that the tip of the vapr hook electrode 3.5mm device started to melt.It was reported that the procedure was finished by the time it was noticed that the tip had melted.There was no adverse patient consequences or surgical delay reported.No additional information was provided.
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.H6: the actual device has been returned.And is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent 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.Investigation summary- the device was received and evaluated.Visual inspection revealed that the electrode is in used condition.The cable was cut by the customer.The active tip shows signs of activation.The black sleeve was found damaged, apparently by high temperature.The electrode will be sent to the manufacturer for further analysis.Manufacturer analysis result for vapr 3.5mm hook 1-piece electrode -ea: device was received in the blister tray.Active tip and ceramic remain in good condition, however, the heatshrink as peeled back at the distal end of the device.Handle assembly is in good condition.Cable and plug had been cut off.No damage to the shaft or other areas of damage.The electrical and functional tests were not performed due to cable cut off.The customer stated that 'tip of the electrode was start to melt'.Visual inspection found the distal end of the heatshrink< damaged.The heatshrink had been pulled back, no other damage visible on the remainder of the heatshrink.It is not clear what caused this damage to the heat shrink.No other testing was possible as the plug and cable had been cut off.Based on the event information received and the heat shrink damage observed we have determined the likely cause of the reported defect to be excessive mechanical force used during the procedure resulting in the heat shrink peeling back.A review of our complaint records shows this defect to be an isolated case.The failure mode seen is considered to be in line with the expected outcome and frequency rate detailed in systems risk assessment document, and no further action is recommended.The overall complaint was confirmed as the observed condition of the vapr 3.5mm hook 1-piece electrode -ea would contribute to the complained device issue.Based on the investigation findings, 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 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 number, 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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18968930
• Report Number: 1221934-2024-00972
• Device Sequence Number: 20506730
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: 10886705009718
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 08/31/2026
• Device Catalogue Number: 227305
• Device Lot Number: U2309070
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/15/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/12/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown