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

Model Number 214141

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 04/20/2023

Event Type  malfunction  

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.H10 additional narrative: udi: (b)(4).E3: reporter is a j&j sales representative.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.Investigation summary: two photos were returned to depuy synthese mitek for evaluation.The depuy synthese mitek team conducted a visual inspection of the returned photos.Visual analysis of the photos revealed that three espressew are over a table along with another devices, the three expressews are not identified with their corresponding lot number, in the second photo, it was noted that one of the three expressews has a needle stuck, a partial part of the needle is out of the device through the lower jaw.Another needle appears to be inserted in other expressew, is not possible to verify its condition.The rest of the needles are not shown in the photo.A manufacturing record evaluation was performed for the finished device lot number: 69349, and no non-conformances were identified.As part of depuy synthese mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual evaluation findings, this complaint was confirmed, only the condition of one needle is shown in the photo which is stuck in the expressew gun, the rest of the needles reported are not visible in the photos provided, hands on analysis should provide the require evidence to determine a root cause for the issue reported for the remaining needles.A possible root cause for the needle stuck can be attributed to an improper maintenance of the expressew gun that would lead to bio-debris build up inside the expressew shaft causing deployment issues, the operator attempt to remove the needle through the lower jaw.However, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

This is report 7 of 8 for(b)(4).It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the expressew iii needle device would not capture the dynatape.During in-house engineering evaluation of the photos provided by the customer, it was determined that a needle was stuck in the expressew device; and that a partial part of the needle was out of the expressew gun device through its lower jaw.Another like device was used to complete the procedure with over an hour delay.There were no adverse patient consequences reported.No additional information was provided.

• 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: 17240531
• MDR Text Key: 318342123
• Report Number: 1221934-2023-02576
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• 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: 69349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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