MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number 3N08A

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2 - a4: age, gender, and weight were requested, but not provided.B3: date of event was requested, but not provided, therefore the date ((b)(6) 2023), gore received the information will be used as date of event.H3: phr and engineering evaluation pending and will be sent on the follow up report.H6 - code 4111: additional information regarding the event were requested from the physician.The provided additional information is captured in the event description.The gore-tex® suture instructions for use (ifu) states: misuse of this suture, like any other suture, can result in severe injury or death to the patient.As with any suture, care should be taken to avoid damage when handling.Avoid crushing or crimping the suture with surgical instruments or exposing the suture to sharp edges.In order to minimize needle damage, do not drive the needle from the channel where the suture is attached.Needles are not intended to be implanted.At least seven, equally tensioned, flat square throws are required to produce a secure knot when tying gore-tex® suture.Additional throws may be necessary depending on surgical circumstances.When tying knots with the gore-tex® suture, tension should be applied by pulling each strand of the suture in opposite directions with equal force.As the knot is tensioned, the air in the suture is forced out.Care should be taken to avoid using a jerking motion which could break the suture.Uneven tensioning of a well formed square knot may result in an unsecure knot.When the gore-tex® suture is properly tensioned and formed, standard surgical knotting techniques will produce a secure knot.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported by the customer that when the doctor tried to use gore-tex® suture, it began unraveling on him.Reportedly, he put about 10 knots in the suture and it continued to unravel.It was reported a new box was opened and the sutures unraveled on the doctor again when attempting to use them on the patient.Reportedly, the doctor took them all out and re-sutured the patient.The complainant ((b)(6)) confirmed the unravelling occurred during the procedure.She was not able to confirm any additional details.

Manufacturer Narrative

A review of the associated manufacturing records indicated that suture lot 2005762 was manufactured according to approved procedures and met all release specifications.Since no device was returned, no further evaluation could be performed.As such, there is no discernible root cause associated with this event.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE-TEX® SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: angela brown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17420147
• MDR Text Key: 320089126
• Report Number: 3003910212-2023-01476
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 00733132602711
• UDI-Public: 00733132602711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P820083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3N08A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other