MAUDE Adverse Event Report: ETHICON, LLC ETHIBOND EXCEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Model Number X524H

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

0-sh needle from ethibond excel® polyester suture kit broke while suturing a patient.When needle driving through the fascia 4/5th's of the needle broke off presumably in the skin.X-ray anteriorposterior and lateral of chest taken, needle not found on x-ray read by radiologist.Examination of surgical field and suite with use of magnet performed, no needle fragment found.

• Brand Name: ETHIBOND EXCEL
• Type of Device: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 11782856
• MDR Text Key: 249290432
• Report Number: 11782856
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X524H
• Device Catalogue Number: X524H
• Device Lot Number: QHMAZB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Date Report to Manufacturer: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA