MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR HOOK ELECTRODE 3.5MM HOOK ELECTRODE W/INTEGRATED HANDPIECE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227305
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, it was observed that the white part of the hook of the vapr hook electrode 3.5mm hook electrode w/integrated handpiece device broke.Another like device was used to complete the procedure.No 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Initial reporter occupation: reporter is a (b)(4) sales representative.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the device was received and evaluated.Visual inspection revealed that the electrode is in normal use condition.The cable and the suction tube were cut by the customer.Upon reviewing the active tip, it was found broken.The electrode will be sent to the manufacturer for further analysis.Manufacturer evaluation result for vapr 3.5mm side str - ea: the device has not been returned in its original packaging.The ceramic has fractured resulting in the ceramic separating into two.The ceramic remains attached to the device.The device shaft is deformed.The hook is also distorted from its original alignment.The distal end of the heatshrink is damaged.The electrical test was performed, as a result, all parameters passed.Functional testing was conducted, the device was connected to vapr vue generator; no issues were found.Manufacturer summary: visual inspection of the device confirms the customer report of 'the white part of the hook of the vapr hook electrode 3.5mm hook electrode w/integrated handpiece broke'.Based on the condition of the device shaft we have determined the root cause of the failure to be excess mechanical force during use - misuse, therefore no further investigation is possible.The ceramic has fractured and separated into two pieces which remain attached to the device and there is no evidence that any ceramic fragments fell inside the patient.A risk assessment has been performed for the reported defect seen where a section of device breaks during use and potentially falling within patient and all components are retrieved during the current procedure, line 480 of the product ra risk matrix applies.The severity risk category is ¿serious¿- results in injury or impairment requiring professional medical intervention.For this scenario a pre mitigation risk of grid 14 and a post mitigation risk of grid 14 are stated, which is ¿serious¿ and ¿probable¿ and rated as low as reasonably achievable (alra).Dhr review has been performed for the complaint device lot number u2110070; no issues (ncrs or deviations) with the manufacturing process have been indicated.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.D9, h3, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VAPR HOOK ELECTRODE 3.5MM HOOK ELECTRODE W/INTEGRATED HANDPIECE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• 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: 15799340
• Report Number: 1221934-2022-03573
• Device Sequence Number: 3009951
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: 10886705009718
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 09/30/2024
• Device Model Number: 227305
• Device Catalogue Number: 227305
• Device Lot Number: U2110070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 12/21/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 11/18/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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