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

Model Number	4U16A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
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, therefore an engineering evaluation could not be performed.Per the instructions for use (ifu) for the 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.
Event or Problem Description
It was reported to gore by the product specialist that on (b)(6) 2020 a breast reduction mammaplasty and areola reconstruction was performed on the breast using the 4u16a gore-tex® suture.The needles were removed and the suture was attached to a keith needle for the procedure.On (b)(6) 2021 the physician observed that the suture had broken.It was reported the patient will return for a re-operation, but a date has not been scheduled yet.
Additional Manufacturer Narrative
G3/g4: added pma/510(k)number p820083.

• 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: 11247655
• Report Number: 3003910212-2021-01162
• Device Sequence Number: 3563698
• Product Code: GAW
• UDI-Device Identifier: 00733132603138
• UDI-Public: 00733132603138
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 4U16A
• Device Catalogue Number: 4U16A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 32 YR
• Patient Weight: 67