MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEXICO QUILL; BARBED SUTURE / NEEDLE

Model Number RA-1012Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scarring (2061)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the device history records, exposure records and sterility records for the reported finished good lot and review of raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.No samples were returned for review/testing.There were no retained samples available for testing/review.Photos were provided by the end user.The photos display the presence of scarring and high skin tension in the area of the incision, from previous procedure performed.The incision was photographed (b)(6) 2019.The initial beauty enhancement procedure was performed (b)(6) 2019, 43 days prior to the photo of the healing incision with a few spots still remaining swollen and red.The 2nd photo taken on (b)(6) 2020 shows the incision healed; fully closed; good coloring.Note: the results of implantation studies in animals using quill comprised of dyed pdo indicate that for sizes 3-0 and larger, approximately 80% of the original strength remains after two weeks and four weeks of implantation.At six weeks post implantation, approximately 40% to 70% of the original strength is retained.For size 4-0, approximately 67% of the original tensile strength remains after two weeks, approximately 50% at 4 weeks, and approximately 37% at 6 weeks.Data obtained from implantation studies show that absorption of quill comprised of dyed pdo is minimal until about 120 days, and is essentially complete within 180 days (six months).A definitive root cause for the reported event of wound healing/absorption failure/suture spitting cannot be confirmed with certainty.As stated in the ifu for the devices, wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures spitting or reaction, infection, abcess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, sutures placed too superficially, over-tightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise, heavy lifting, recurrent vomiting, coughing or an improper diet that leads to constipation.Without testing/reviewing sterile samples from the same finished good lot or receiving pertinent details regarding the preoperative preparation of the devices, exposure time prior to the procedure, procedure performed, the surgeon¿s technique, details regarding placement of the material, technique utilized to secure the device in the tissue or post-operative events that may have occurred and/or contributed to the wound healing issues, a definitive root cause cannot be determined at this time.

Event Description

During a low-segment cesarean section performed on (b)(6) 2019, it was observed that the patient had physical scars and high skin tension, ra-1012q was used for the patient¿s beauty enhancement procedure.Since (b)(6) 2019, the absorbable suture has repeatedly been spitting, poking from skin; not-absorbing, thread has been emerging which lead to the exudation of the wound.Then iodine volt was used for dressing disinfection, and the wound was finally healed on (b)(6) 2020.

• Brand Name: QUILL
• Type of Device: BARBED SUTURE / NEEDLE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION MEXICO; #24702 b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 10090220
• MDR Text Key: 196640031
• Report Number: 3010692967-2020-00020
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: RA-1012Q
• Device Catalogue Number: RA-1012Q
• Device Lot Number: AADB583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 11/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2020
• Date Manufacturer Received: 04/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR