MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2FS 2-0 PDO 24 X 24

Model Number SXPD2B419

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Impaired Healing (2378)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue.Sterile devices were not available for evaluation.The actual devices or photos were not available for review.The retained sample could not be reviewed without receiving the finished good lot number.If the lot number, samples or photos become available at a later time they will be reviewed/tested and the results will be included in the file.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 seven (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 device utilized for this procedure.Without receiving the specific lot number to review the device history record, photos of the actual surgical site/device/spitting suture, sterile devices from the same finished good lot or receiving details regarding the pre-operative preparation of the device, details of the layer of tissue where the device was placed, method utilized to secure the device in the tissue, patient health status, quality of the tissue utilized to secure the device or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

Event Description

It was reported by our distributor that a patient underwent reduction of dislocation of knee joint with fracture surgery on (b)(6) 2020, the device was used to sew the skin.The suture was found to be extruded intermittently.The suture was removed in 3 times((b)(6) 2021, (b)(6) 2021, (b)(6) 2021) under local anesthesia, then the wound was oozing and the wound finally healed around two months after surgery.The patient is stable now.

Manufacturer Narrative

To clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.¿.

• Brand Name: STRATAFIX SUTURE
• Type of Device: 2FS 2-0 PDO 24 X 24
• Manufacturer (Section D): SURGICAL SPECIALTIES; rd 495 montana industrial park; tijuana 22235 ; MX 22235
• MDR Report Key: 11607281
• MDR Text Key: 260128475
• Report Number: 3010692967-2021-00011
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/05/2021,06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B419
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention