MAUDE Adverse Event Report: DEPUY MITEK LLC US ANGLED END EFFECT ELECTRODE, 21º; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225304
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
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 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).The initial reporter is a j&j employee.Investigation summary: the complaint device was received and evaluated.Visual inspection revealed that signs of activation on the active tip.The vapr hand piece used was not received for evaluation.The device was sent to the manufacturer for further testing.The visual inspection of the device was performed; as a result, the device not returned in the original packaging, no handpiece returned, no clear signs of activation, signs that device was connected to a handpiece.The investigation established that the return wire was no longer soldered to the return tube.The wire had become detached resulting in no continuity on the return circuit and no activation during the ablate and coagulate mode.A dhr review has been performed for the complaint device lot number u2103156; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.During our investigation we have been able to confirm an electrical fault.The root cause of the defect can be assigned to a manufacturing defect due to an inadequate solder bond being applied during manufacturing at process id 110 fit and solder pcb as per assy aid 515352 causing the return wire to become detached - human error.It is likely the poor solder bound was making an intermittent contact during the manufacturing process which allowed the device to pass electrical testing at process id 135 and then deteriorated further during transportation.The assignable root cause relating to this complaint is the manufacturing process.A capa investigation had already been completed to further investigate similar failure.A correction action from this capa was the retraining operators within cr1 against the current assembly aid 515352 process id 110 fit and solder pcb which should help prevent recurrence of this defect.The customer's device was manufactured in apr 2021 which was prior to this correction.In addition to the retaining preformed as part of continuous improvement the assembly aid 515352 was updated with an improved method of soldering which will allow the continued best practice for this soldering process.As detailed in the product control plan document 920576-gt this product is 100% electrically tested at process id 135 - check continuity active & return as part of its product test regime, therefore all reasonable containment is in place and additional containment work is not considered necessary.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.
Event or Problem Description
It was reported by the affiliate in japan that during an unknown procedure on (b)(6) 2022, it was observed that the angled end effect electrode, 21º device did not run.During in-house engineering evaluation, it was determined that the return wire was no longer soldered to the return tube.According to the investigation, the wire had become detached resulting in no continuity on the return circuit; and therefore, no activation during the ablate and coagulate mode.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.

• Brand Name: ANGLED END EFFECT ELECTRODE, 21º
• 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: 16412285
• Report Number: 1221934-2023-00839
• Device Sequence Number: 17550941
• Product Code: GEI
• UDI-Device Identifier: 10886705009282
• UDI-Public: 10886705009282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992406
• 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

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: 02/28/2026
• Device Model Number: 225304
• Device Catalogue Number: 225304
• Device Lot Number: U2103156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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