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

Catalog Number	P5K17A
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
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, but an engineering evaluation was performed.Because the device was not returned by the customer, it was not possible to perform a physical analysis of the device that would include images.Based on the information available the root cause for the complaint is unknown.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.
Additional Manufacturer Narrative
B4.Date gore aware of reportability 11/13/19.

• 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: 9401891
• Report Number: 3003910212-2019-00495
• Device Sequence Number: 11304469
• 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,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: P5K17A
• Device Lot Number: 20659205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1