MAUDE Adverse Event Report: TELEFLEX MEDICAL ULTRABRAID WH/BLU MULTI BR 5 40" HC-5 1N S&N; SUTURE, NONABSORBABLE, SYNTHET

Catalog Number	72205429
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that: "during an unspecified procedure, two (2) ultrabraid sutures broke when put under tension.The procedure was completed by modifying the protocol and using sutures with an older technique.It is unknown if there was a surgical delay and no further complications were reported".No report of patient harm or injury.See associated mdr# 3004365956-2025-00002.

• Brand Name: ULTRABRAID WH/BLU MULTI BR 5 40" HC-5 1N S&N
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHET
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 21254441
• Report Number: 3004365956-2025-00001
• Device Sequence Number: 9117077
• Product Code: GAT
• UDI-Device Identifier: 34026704735250
• UDI-Public: (01)34026704735250(11)220202(17)270202(10)74B2200477(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72205429
• Device Lot Number: 74B2200477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown