MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	P5K17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight requested, but not provided.The physician reported the gore-tex® suture cv5 suture ruptured several times over a period of 6 months.The physician reported he did not record the occurrences when the suture ruptured or capture any patient details.The instructions for use (ifu) for gore-tex® suture provides the following precautions among others, "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.".
Event or Problem Description
It was reported to gore that the gore-tex® suture cv-5 (p5k17a) changed from a more flat form to a round and thinner form that easily breaks.The physician did change to a p4k13a in hopes that it is stronger and more resistant.

• Brand Name: GORE-TEX® SUTURE CV5
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9616628
• Report Number: 3003910212-2020-00004
• Device Sequence Number: 546999
• Product Code: GAW
• UDI-Device Identifier: 00733132628506
• UDI-Public: 00733132628506
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 12/31/2023
• Device Model Number: P5K17
• Device Catalogue Number: P5K17A
• Device Lot Number: 20659205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1