MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III SUTURE PASSER W/ HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 214124

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep that during an arthroscopic shoulder repair procedure on (b)(6) 2023, it was observed that the expressew iii suture passer w/ hook device had an unspecified malfunction.During in-house engineering evaluation, the device was tested for functionality where a needle was loaded into the device and was tested on a sample rubber strip.According to the evaluation, when the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue.To restore it to the original position, the needle trigger had to be pushed back manually.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.Udi: (b)(4).The expiration date is currently unavailable.Reporter is a j&j sales representative.The device manufacture date is currently unavailable.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed wear marks.To test its functionality, an eiii needle was loaded into the device and was tested on a sample rubber strip.When the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue.To restore it to the original position, the needle trigger must be pushed back manually.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.According with the results, this complaint can be confirmed.The possible root cause for deployment issue can be attributed an improper maintenance would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.As per ifu-110114, it is important to inspect the device prior to use to ensure proper mechanical function.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-solubel lubricant in accordance with the manufacturer¿s instructions.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.Visual and dimensional inspection: drawing: pn 214124 dwg-110049.Device history lot: null.Device history batch: null.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• Brand Name: EXPRESSEW III SUTURE PASSER W/ HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• 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: 16823526
• MDR Text Key: 314093929
• Report Number: 1221934-2023-01851
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: 10886705003655
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214124
• Device Catalogue Number: 214124
• Device Lot Number: 22932-140304-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1