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

Model Number 214141

Device Problems Break (1069); Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 12/31/2022

Event Type  malfunction  

Event Description

This is report 1 of 2 for (b)(4).It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, it was observed that the expressew iii needle device got stuck in the expressew iii suture passer w/o hook device while in use together.During in-house engineering evaluation, it was observed that the expressew iii needle was found stuck inside the expressew gun that it was not possible to remove it from the expressew iii suture passer w/o hook device.It was further determined that the needle tip was broken.Another like devices were 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.H4: the device manufacture date is currently unavailable.Investigation summary: the device was received and evaluated.Upon visual inspection, the device does not show any structural anomalies.Upon reviewing the upper jaw, it was found that is loose.When the trigger was fully depressed, the jaw cannot be closed completely.The jaw hinge is damaged.The needle was found stuck inside the expressew gun and it is not possible to remove it from the expressew gun.The needle tip is broken.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.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the loose jaw can be attributed to procedural variables, such handling of the device or product interaction during procedure, a bigger portion of tissue may have been grabbed and forced the jaw to close, therefore the jaw hinge was damaged and the jaw become loose.The possible root cause for the stuck and broken needle can be attributed to repeatedly passing the needle through excess tissue; any use beyond this would cause the needle to fatigue and then break and stuck inside the gun.Also, it could be related when deploying the needle with the jaws open, which can lead to a broken needle, however, this cannot be conclusively determined.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 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: 16864632
• MDR Text Key: 314505829
• Report Number: 1221934-2023-01898
• 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

• 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: 40417-161220-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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