MAUDE Adverse Event Report: DEPUY MITEK EXPRESSEW III SUTURE NEEDLE

Catalog Number 214141

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

Tip of suture passer broke off when the surgeon was passing the suture through the tendon of the left shoulder, c-arm brought in and tip of suture passer was located and retrieved and no injury noted.

• Brand Name: EXPRESSEW III SUTURE NEEDLE
• Type of Device: EXPRESSEW III SUTURE NEEDLE
• Manufacturer (Section D): DEPUY MITEK; raynham MA 02767
• MDR Report Key: 7533851
• MDR Text Key: 109103423
• Report Number: MW5077363
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 214141
• Device Lot Number: 45230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77