MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; 2FS-2 2-0 UNDYD MONODERM 30X30

Model Number SXMD2B408

Device Problem Material Fragmentation (1261)

Patient Problems Wound Dehiscence (1154); Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records for the finished good lots, did not identify any quality issues during the manufacturing, in-process or final inspection processes to date there have been no used or sterile samples available for visual evaluation testing.There are no retained samples to do testing.Without receiving samples to review/test or receiving details regarding the pre-operative preparation of the device, procedure performed, the surgeon¿s technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the report of wound dehiscence, a definitive root cause cannot be determined at this time.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.In vivo studies demonstrate that the monoderm device retains approximately 42%-62% of its original strength 7 days post implantation and approximately 27%-47% of its original tensile strength at 14 days post implantation.Absorption of monoderm¿ device is essentially complete between 90 and 120 days.

Event Description

It was reported by the end user the patient returned post-op after thr surgery with dehiscence and remnants of the suture in the wound.A second procedure was utilized to remove the suture remnants.

Manufacturer Narrative

A review of the device history records for the finished goods and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.No other complaints were received for this finished good lot.The sterilization certificate for this particular lot was reviewed in detail and the method and all results meet the required guidelines.Although samples from the reported lot were not received for review, the retained samples from the device history record was visually and functionally tested.No defects were observed on suture.The device met the current specifications for a pga-pcl 2-0 suture including the usp tensile requirements.The ¿adverse reactions¿ section in the ifu for the stratafix¿ spiral pga-pcl device states, ¿adverse effects associated with the use of this device may include, wound dehiscence, failure to proide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when 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.¿ without reviewing photographs of the incision or receiving pertinent details regarding the pre-operative preparation of the device, exposure time prior to use, method utilized to anchor the device in the tissue, procedure performed, surgeon''s technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reports inflammation/skin reaction, results of culture or blood screen to identify a possible infection/reaction and antibiotics/medications prescribed, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Type of Device: 2FS-2 2-0 UNDYD MONODERM 30X30
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana PR ; MX
• MDR Report Key: 9444421
• MDR Text Key: 185539086
• Report Number: 3010692967-2019-00040
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SXMD2B408
• Device Lot Number: AADL188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention