MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2V-4 3-0 PDO 24 X 24

Model Number SXPD2B426

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Ulcer (2274)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.To date samples or photos have not been returned for review and/or analysis.Without receiving details of the procedure, placement of the device, culture results and patient health history, a definitive root cause for the reported event of infection cannot be confirmed with certainty adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation which skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the barbed suture device.Pdo (polidioxanone) material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.

Event Description

Post-op infection.This case is from health authority.It was reported that the patient was treated with a johnson & johnson surgical knot- free suture for the caesarean section incision suture.About two months plus later, it was found that the wound sewed had been infected.The thread tip of the suture had been extruded out of the abdominal incision, where also had an ulcer.The incision was currently healed after cutting.

• Brand Name: STRATAFIX
• Type of Device: 2V-4 3-0 PDO 24 X 24
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 12561748
• MDR Text Key: 274288415
• Report Number: 3010692967-2021-00043
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 20705031207933
• UDI-Public: (01)20705031207933(20)12(17)250930(10)AAGU335
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2021,10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B426
• Device Lot Number: AAGU335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR