MAUDE Adverse Event Report: DEPUY MITEK EXPRESSEW II FLEXIBLE SUTURE PASSER; ARTHROSCOPIC SUTURE/NEEDLE PASSER

Catalog Number 214004

Device Problem Device Damaged by Another Device (2915)

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

Event Date 09/12/2017

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.No udi# exists for the specified product code.See associated medwatch: 1221934-2017-10566.

Event Description

The affiliate reported via email during use of the expressew gun, the e111 needle 214141 snapped and a portion of needle has become stuck in distal end of the expressew 11 gun 214040.Broken fragment removed and discarded.Replacement gun and needle used without incident.No ae to patient.No delay to procedure.Additional information received via email from the affiliate on 9-21-2017: do you know how many passes were made prior to the break? unknown.When did the breakage occur? unknown.Were there any procedural or patient anatomy factors which may have contributed to the breakage? no.All available information have been provided.None further is available.

Manufacturer Narrative

The complaint device was received and visually inspected.Visual observations revealed no anomalies on the expressew gun.The laser markings are slightly faded but readable.It was noticed that a broken needle tip found jammed at distal tip of expressew gun.The needle body was not present inside the gun.This complaint can be confirmed.As this is a reusable device, it is possible that tissue debris was lodged inside the shaft at the distal end and without proper cleaning/ sterilization; the device would become rough to operate over time and the needle might have got jammed.Other than this possibility, we cannot discern a root cause for this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices 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.No udi # exists for the specified product code.See associated medwatch: 1221934-2017-10566.

• Brand Name: EXPRESSEW II FLEXIBLE SUTURE PASSER
• Type of Device: ARTHROSCOPIC SUTURE/NEEDLE PASSER
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6934793
• MDR Text Key: 90047750
• Report Number: 1221934-2017-10567
• Device Sequence Number: 1
• Product Code: LXH
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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 Catalogue Number: 214004
• Device Lot Number: K4249KS-101118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1