MAUDE Adverse Event Report: DEPUY MITEK LLC US SIDE EFFECT ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225301
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep in south korea that the side effect electrode had an unspecified malfunction.During in-house engineering evaluation, it was determined that the adhesive was visible between the spring coils on the device.There was no procedure nor patient involvement 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).Investigation summary this complaint was created to address two extra devices received under (b)(4).The two vapr 3.5mm side str -ea (extras) were returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of the devices received by customer.Upon visual inspection of the second device, the two devices were returned in the original packaging.For the second device, the measurements taken show that the acceptance criteria for height difference and gap was achieved.However, epotek is visible between and on the coils which is failure according to visual standard r78.; also, the solder was also missing on the active connection on the pcb.The continuity was still within specification.A dhr review has been performed for the complaint device lot number u2108050; 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 ra no containment or correction action related to the individual complaint is required.Despite some variance in the coil heights, the measurements of the spring coils for all 3 returned electrodes were found to be within the manufacturer¿s specification.A defect was observed for in the second device during the investigation, adhesive was visible between the spring coils; it was also noted that the solder on the active wire pcb connection had broken away exposing the internal active wire.This product is subject to a 100% visual tip inspection at process 135 which includes a check for any adhesive visible between coils.The information regarding the excessive adhesive has been shared with the relevant manufacturing team leader and production team members who assemble the product.This information will provide an awareness of the event and describe the potential impact of such an error caused within the manufacturing process.An observation was made of insufficient solder on the active connection to the pcb.Electrical testing shows continuity was still within specification.A capa investigation has already been completed to further investigate similar soldering defects.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.In addition to the retaining preformed as part of continuous improvement the assembly aid has now been updated with an improved method of soldering.The customers devices were manufactured in sep 2021 which is prior to these corrective actions.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.Device history lot a dhr review has been performed for the complaint device lot number u2108050; 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 ra no containment or correction action related to the individual complaint is required.

• Brand Name: SIDE EFFECT ELECTRODE
• 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: 14853195
• Report Number: 1221934-2022-01904
• Device Sequence Number: 20035670
• Product Code: GEI
• UDI-Device Identifier: 10886705009251
• UDI-Public: 10886705009251
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 07/31/2026
• Device Model Number: 225301
• Device Catalogue Number: 225301
• Device Lot Number: U2108050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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