MAUDE Adverse Event Report: DEPUY MITEK LLC US S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 227355

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/17/2023

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the s50 3mm/50º suction electrode w/ integrated handpiece device had no suction when connected to the aspirator inside the articular cavity; and that even back flushing with a syringe still did not work.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).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.

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.Device was used for treatment, not diagnosis.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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> a video was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned video.Visual analysis of the video reveled that an arthroscopic image is shown in which was noted that the device suction is not working as intended.Suction ports could not be clearly observed.No further information was provided.A manufacturing record evaluation was performed for the finished device lot number: u2301138, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection of the video provided, this complaint can be confirmed.Multiple factors could be associated with this type of failure, the device is required for testing, hands on analysis should provide the required evidence to provide a root cause.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 surveillance.

• Brand Name: S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA
• Type of Device: 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: 17650809
• MDR Text Key: 322286934
• Report Number: 1221934-2023-03235
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009732
• UDI-Public: 10886705009732
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227355
• Device Lot Number: U2301138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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