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

Catalog Number 214140

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Visual observations revealed the device was slightly worn, used but in expected condition.The lower jaw of the device appeared to be slightly bent.When the trigger was pulled by itself, it functioned as expected.To test the device functionality, an expressew iii needle was loaded onto the device and tested on a sample rubber pad.When the trigger was actuated, there was slight resistance and the deployment was rough.Much force needed to be applied in order to deploy the needle.The reported complaint was confirmed.This device is required to be thoroughly cleaned and properly lubricated/ milked to avoid friction during deployment.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.Further, functional testing revealed that there was a definite gap observed when the rubber pad was placed between the two jaws confirming the visual observation of the lower jaw being bent slightly.This failure is consistent with the device hitting bone during a procedure or being mishandled/ dropped (or indicates blunt force impact).A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into depuy synthes mitek complaints system revealed one dissimilar complaint for this lot of devices with the product code that were released to distribution.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.(b)(4).

Event Description

The sales rep reported via phone that the customer's expressew iii without hook would not fire the needle during a rotator cuff repair.The case was completed with another like device.There were no patient consequences or delays.The device is being returned.

• Brand Name: EXPRESSEW III SUTUER 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7542795
• MDR Text Key: 109239585
• Report Number: 1221934-2018-50835
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2018

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 Catalogue Number: 214140
• Device Lot Number: 11090-120329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/24/2018
• Date Device Manufactured: 04/02/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1