MAUDE Adverse Event Report: TELEFLEX MEDICAL FFB BL CO-BR 2 HC-5 1N 38" STRYKER; SUTURE, NONABSORBABLE, SYNTHE

Catalog Number	3910-900-020
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "in a tenorrhaphy in the achilles.At the time of the stitch step, the needle is disconnected from the force fiber suture without any force having been exerted".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Udi#: (b)(4).
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.
Event or Problem Description
It was reported "in a tenorrhaphy in the achilles.At the time of the stitch step, the needle is disconnected from the force fiber suture without any force having been exerted".No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: FFB BL CO-BR 2 HC-5 1N 38" STRYKER
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19734038
• Report Number: 3004365956-2024-00054
• Device Sequence Number: 7108067
• Product Code: GAT
• UDI-Device Identifier: 14026704603395
• UDI-Public: (01)14026704603395(11)230301(17)280301(10)74C2300160(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K063778
• 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,Followup
• Report Date (Section B): 06/14/2024

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 Catalogue Number: 3910-900-020
• Device Lot Number: 74C2300160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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