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

Model Number 214140

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983); Unintended Movement (3026)

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

Event Date 11/23/2022

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.Udi: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual and functional inspection of the device received.Upon visual inspection revealed wear marks on the device; also, the upper jaw was slightly loose and did not close normally contributing to the holding issue the rest of the device is in normal condition.To test its functionality, it was tested on a sample rubber strip and a needle; as a result, the needle was not functioning as expected due to it was very hard to deploy causing the needle stuck in the shaft.The trigger had to be manually pushed back to retract the needle to its original position.A manufacturing record evaluation was performed for the finished device 7353 number, and no non-conformances were identified.According with the visual and functional inspection result, this complaint can be confirmed.The manufactured date of this device is 2011 and hence indicates this device is 11 years old.The possible root cause for the issue experienced can be attributed to an improper maintenance would lead to tissue or bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However, this cannot be conclusively determined.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function and do not use if product is damaged.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-solubel lubricant.Applying too much force when grasping tissue will impede passage of the needle and suture.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.

Event Description

The expressew needle got stuck in the device multiple times.Two needles were attempted to be used and both malfunctioned.The white plastic tab broke off and the needles became stuck in the device.The needles are not available to be sent back.No patient harm or case delay.It was reported by the sales rep that during an unknown procedure on 11/23/2022, it was observed that needles got stuck in the expressew iii suture passer w/o hook device.During in-house engineering evaluation, it was determined that the upper jaw was slightly loose and did not close normally contributing to the holding issue.It was further determined that the device was very hard to deploy the needle causing the needle to get stuck in the shaft; and that the trigger had to be manually pushed back to retract the needle to its original position.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: EXPRESSEW III SUTURE PASSER W/O 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: 16227097
• MDR Text Key: 307944252
• Report Number: 1221934-2023-00429
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: 10886705020218
• 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: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214140
• Device Catalogue Number: 214140
• Device Lot Number: 7353-110615-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1