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

Catalog Number 214124

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure the tip of the customer's expressew iii with hook is bent causing the jaw to not close all the way.The sales rep stated that the surgeon was struggling to pass the needle.The procedure was able to be completed with the device with no harm to the patient but there was a minute delay due struggling with getting the needle to pass with the device.The device will be returning for evaluation.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  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.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.Udi:(b)(4).

• Brand Name: EXPRESSEW III SUTUER PASSER 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: 7575221
• MDR Text Key: 110464044
• Report Number: 1221934-2018-51419
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

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: 214124
• Device Lot Number: 36378-160316
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1