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
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Additional 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.If samples become available at a later time, they will be reviewed and a follow-up report submitted.Adverse effects associated with the use of this or any 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, suture spitting, 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 (possible spitting).Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.Without receiving details of the procedure, placement of the suture, timeline/days suture remained in place or began spitting, patient health history, post-operative instructions and adherence to doctor¿s orders or surgeon¿s technique, a definitive root cause for the reported event cannot be confirmed with certainty.
Event or Problem Description
The patient had c-section surgery in (b)(6) 2021 due to scarred uterus.And was discharged 3 days after operation.(b)(6), the patient came to the hospital for reexamination and complained of poor wound healing, unabsorbed suture, and the appearance of the suture came out from skin, and the hospital removed the unabsorbed suture and asked for clarification from company.Clinical feedback that it maybe related to suture absorption degradation too slow and foreign body reaction.

• Brand Name: STRATAFIX
• Common Device Name: 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
• MDR Report Key: 12672752
• Report Number: 3010692967-2021-00047
• Device Sequence Number: 3706494
• Product Code: NEW
• UDI-Device Identifier: 20705031207933
• UDI-Public: (01)20705031207933(20)12(17)250930(10)AAGU334
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021
• Report Date (Section F): 10/12/2021

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: 10/01/2025
• Device Model Number: SXPD2B426
• Device Lot Number: AAGU334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/10/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 32 YR