MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2CTX #2 PDO 36 X 36

Model Number SXPD2B405

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

To date a lot number has not been provided and therefore we are unable to perform a lot review, including sterility records, to determine if there were any non-conformances reports with this issue to date samples have not been returned for review and analysis.A definitive root cause for the reported event of infection cannot be confirmed with certainty.However, according to the details received it appears the infection may have been caused due to reported post-op activities.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

It was reported by the sales representative of our distributor that; post operative after a knee procedure the patient presented with an infection.The patient stated that she stepped into a goat pen which submerged her knee.The surgeon reopened the knee and found that the suture was in pieces and there was puss in the capsule.A different type of suture was used to close the wound suture was used to close the wound.

• Brand Name: STRATAFIX SUTURE
• Type of Device: 2CTX #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 11123487
• MDR Text Key: 225283213
• Report Number: 3010692967-2021-00002
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020,01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B405
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention