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 02/07/2023

Event Type  malfunction  

Event Description

It was reported by a healthcare professional that postoperatively to an unknown arthroscopic procedure on (b)(6) 2023, it was observed that an expressew iii needle device was stuck in the expressew iii suture passer w/o hook device that could not be removed.During in-house engineering evaluation, it was determined that a needle was found stuck in the shaft of the device.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 device manufacture date is currently unavailable.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual inspection revealed that the needle was found stuck into the shaft of the device, the white plastic flag was not returned.It was not possible to remove the needle.A manufacturing record evaluation was performed for the finished device 67255, and no non-conformances were identified.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 deployment issue 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, another possible root cause for the needle stuck can be attributed to the white plastic flag fell off causing the retracting mechanism to be jammed with the needle inside, 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 track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• 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: 16673738
• MDR Text Key: 312614720
• Report Number: 1221934-2023-01466
• 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: 67255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/04/2023
• 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