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 Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cross reference report number: 3003910212-2020-01040.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.
Event or Problem Description
It was reported to gore that when using gore-tex® suture (cv-2, item 2m25a) it kept coming apart from an unknown area after the knot was tied.It was reported there was 5 total in the box.Two will be captured in this event and the other three are captured in (b)(4).
Additional Manufacturer Narrative
Reportable malfunction with no specimen return.The engineering investigation revealed based on the information available the reported issue could not be confirmed and no root cause could be determined.Investigation determined that risks associated with the reported issue are addressed in the risk management file.A review of manufacturing records confirmed that the lots associated with the issue met all acceptance criteria.

• 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
• MDR Report Key: 10434820
• Report Number: 3003910212-2020-01041
• Device Sequence Number: 3669603
• Product Code: GAW
• UDI-Device Identifier: 00733132602186
• UDI-Public: 00733132602186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 06/30/2024
• Device Model Number: 2M25A
• Device Catalogue Number: 2M25A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 66