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

Model Number	2M25A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight requested, but not provided.The device was discarded, so an engineering investigation could not be performed.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was not returned to gore; therefore, an engineering evaluation could not be performed.
Event or Problem Description
It was reported as the physician was preparing to use the gore-tex® suture to sew the nipple on a patient, the suture just fell into pieces.It was reported this occurred with 2 sutures from the same box.Reportedly, one suture could not be kept for analysis as it fell into too many pieces.It was reported one was kept and will be sent back for analysis.Reportedly, the patient is doing well and is stable, however there was some delay to the surgery because of the incident.It was reported another gore suture from another box/lot which worked perfectly.Reportedly, the client mistakenly disposed of the suture that was used.It was reported the device fell into pieces during use.
Additional Manufacturer Narrative
D1- brand name gore-tex® suture updated.Since neither of the devices involved with the incident were returned, the failure could not be confirmed.Manufacturing records were reviewed for and component lot was manufactured according to approved procedures and met all release specifications.Each fiber lot is qc tested for the knotted suture tensile strength characteristic.The knotted suture tensile strength test for the associated cut fiber was reviewed and was confirmed to meet all acceptance criteria.100% of devices undergo visual inspection at cutting.The thread is inspected for damage or any abnormal condition that would produce a tensile strength anomaly.Based on the information available the reported issue could not be confirmed.

• Brand Name: GORE-TEX® SUTURE
• Common Device Name: 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: 14189911
• Report Number: 3003910212-2022-01348
• Device Sequence Number: 4481968
• Product Code: GAW
• UDI-Device Identifier: 00733132602186
• UDI-Public: 00733132602186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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 Expiration Date: 12/31/2025
• Device Model Number: 2M25A
• Device Catalogue Number: 2M25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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 Age: 34 YR
• Patient Sex: Male