MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR90 SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225028

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

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).Reporter is a j&j 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.

Event Description

It was reported by the sales rep in south korea that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the backside part on the tip on the vapr tripolar90 suction electrode device detached while in use.It was unknown how the procedure was completed with a delay of two minutes.There were no adverse patient consequences reported.No additional information was provided.

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.H10 additional narrative: investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it appeared that the ceramic tip was detached.The complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device u2206028, and no non-conformances were identified.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.At this point, a root cause for the issue experienced by the customer cannot be determined.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot that was released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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.H10 additional narrative: 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.

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.H10 additional narrative: investigation summary
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> the device was received and evaluated.Visual inspection revealed that the ceramic tip was detached.The piece was not returned for evaluation.The electrode was sent to the manufacturer for further evaluation.The vapr tripolar 90 suction elect was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection of the device was performed, as a result, the device was not returned in the original packaging, the device active tip is in a used condition, the cut return cap is missing, the cut return cap has not been returned with the device , no visible glue on the ceramic, there is remains of glue on the cut return wire and the device shaft is undamaged and remains straight.Electrical and functional testing not performed due to cap detachment.A dhr review has been performed for lot u2206028; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the product dhr, investigation findings & product risk analysis document no correction or containment action has been recommended.From our initial investigation we were able to confirm the customer reported problem where the return cap has become detached from the ceramic, but we have been unable to determine an exact root cause at this stage therefore further investigation will be required.A capa investigation has already been initiated to investigate this failure mode further and identify any potential preventative /corrective actions, this complaint will be added to the scope of this capa which is currently in the root cause phase.At this point in time, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: VAPR TRIPOLAR90 SUCTION ELECTRODE
• Type of Device: 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: 16060958
• MDR Text Key: 306596604
• Report Number: 1221934-2022-04260
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K143475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U2206028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1