MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW II FLEXIBLE SUTURE PASSER -NS; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214004

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2013

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.Product code: 214004.Evaluation statement: this complaint is being closed since after multiple attempts to retrieve the product, none was made available for evaluation.Through multiple email follow ups, the contact has not responded back with the details for the return of the device in question its return to ethicon for evaluation, a sample has not been received.If and when the device in question is received, this file will be reopened and it's contents made to reflect the results of the evaluation.Furthermore, no correct lot number was supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.Udi: unavailable.No udi number exists for the specified product code.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

The sales rep reported 2 of the customer's healix advanced 4.5mm br anchor's were pulling out of bone holes and the jaw of their expressew ii was bent during a rotator cuff procedure.He stated the surgeon had inserted the first anchor and it pulled out while trying to tie the sutures.The surgeon used another like anchor in that bone hole which held.In a second bone hole, a second anchor pulled out while the surgeon was testing the strength.He used another like anchor in that bone hole which held.The patient had soft bone, a 4.5 healix advanced awl was used, and there were 3 sutures per anchor.The surgeon was using adequate force and had used the healix advance system about 4 times.During the procedure, it was also noticed that the expressew was passing suture poorly.When the surgeon took the device out to look at it, they noticed the jaw on the expressew was bent.The sales rep believes the jaw bent from user mishandling.The surgeon used another expressew to complete the procedure.No patient consequences.The anchor's were already discarded by the customer.The expressew is coming back.Please see also medwatch reports 1221934-2018-50660 and 1221934-2018-50661.

• Brand Name: EXPRESSEW II FLEXIBLE SUTURE PASSER -NS
• 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: 7597507
• MDR Text Key: 111013133
• Report Number: 1221934-2018-50662
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2013

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2013
• Initial Date FDA Received: 06/13/2018
• 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