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

Model Number 214124

Device Problem Difficult to Advance (2920)

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

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).The lot number was unknown.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.

Event Description

It was reported by the sales rep in (b)(6) that during an unknown procedure on an unknown date, it was observed that the needle on the expressew iii sutuer passer w/ hook device stayed blocked.There was no surgical delay nor patient consequences 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 mitek or its employees that the report constitutes an admission that the device, 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.Investigation summary: according to the information provided, it was reported that it was reported that during an unknown procedure the needle of an expressew iii suture passer w/ hook stayed blocked.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The complaint device was received and evaluated.Visual observations revelated that the device was worn due to it was identified a lot of wear marks.Also, it was identified a legend on the device.To test its functionality, an eiii needle was loaded into the device and was tested on a sample rubber strip with a suture; as a result, after several times the needle was not functioning as expected due to it was very hard to deploy causing stuck issue.The trigger had to be manually pushed back to retract the needle to its original position.It was tested with the suture; in consequence the suture was difficult to release.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.According with the visual inspection and the functional test result, this complaint can be confirmed.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.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-soluble 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.

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 mitek or its employees that the report constitutes an admission that the device, 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: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPRESSEW III W/HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11848852
• MDR Text Key: 251423444
• Report Number: 1221934-2021-01580
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: 10886705003655
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1