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

Model Number 214124

Device Problems Bent (1059); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation summary: the complaint device was received and evaluated.Visual observation revealed that the needle is jammed inside the shaft of the gun.It was observed that the needle is stuck between the suture channel of the lower jaw.About 4cm of the distal portion of the needle was protruded through the jaws indicating that the needle was attempted to be pulled out from the distal end of the gun.The flag on the needle that helps the needle load and unload onto the gun was found to be missing.Further, it was observed that the lower jaw is slightly bent.Also, the weld on the lower jaw appears to have been broken, this might have happened possibly while trying to retrieve the needle through the distal end of the gun by force.The failure of jammed needle has historically been attributed to fair wear and tear due to repeated usage and sterilization cycles.The device manufacture date of the gun indicates that the device is more than 5 years old.Hence, the failure can be attributed to fair wear and tear.The failure of the deformed lower jaw may be attributed to user mishandling.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind 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).Associated medwatch: 1221934-2018-50267.

Event Description

It was reported that the needle got stuck when deploying.Could not remove the needle from the gun, resorted to using another company's suture passer.4 minute delay to procedure.No ae to patient.Procedure: rcr.

• Brand Name: EXPRESSEW III SUTURE PASSER W/HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CLASSIC WIRE CUT COMPANY, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7316786
• MDR Text Key: 101875119
• Report Number: 1221934-2018-50266
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: (01)10886705003655(10)8311-111019
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/29/2017

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: 214124
• Device Catalogue Number: 214124
• Device Lot Number: 8311-111019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2017
• Initial Date FDA Received: 03/06/2018
• Date Device Manufactured: 10/21/2011
• 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