MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III NEEDLE; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number 214141

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

This is report 2 of 2 for (b)(4).It was reported by a healthcare professional that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the plastic tabs on two expressew needle devices broke off.Another like device was used to complete the procedure 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.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 nt 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, it was discarded by the customer, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (67860), and no non-conformance was identified.Complaints have been filed regarding the expressew iii needle as part of the expressew iii autocapture flexible suture passer system.This system is indicated for passing suture through tissue in open or arthroscopic surgery.Complaint was received due to the incorrect position of the plastic flag at the proximal part of the expressew needle, and this flag is used to properly load or unload the needle and used to position the needle properly within the expressew iii re-usable instrument.A nonconformance was opened to track this failure with the supplier as well as an internal investigation at the escalation board.A deeper investigation will be performed under this action.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: EXPRESSEW III NEEDLE
• Type of Device: SUTURE/NEEDLE PASSER, 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: 15881731
• MDR Text Key: 307680470
• Report Number: 1221934-2022-03815
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020225
• UDI-Public: 10886705020225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214141
• Device Catalogue Number: 214141
• Device Lot Number: 67860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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