MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; PGA-PCL UNI UD 20CM 2-0 SA

Model Number	SXMD1B405
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot numbers were not provided therefore a review of the device history records, complaint history, sterility records and/or retained samples could not be reviewed.The actual samples were returned for review.No magnified photos of the surgical site/localized infection were provided for review.If the lot number, samples or photos become available at a later time, they will be reviewed, tested and the details will be included as part of the investigation file.A follow-up report will be submitted at that 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.It cannot be confirmed, nor is there any evidence to suggest, that the infections were caused by the devices.
Event or Problem Description
Corza medical / surgical specialties corza medical / surgical specialties was informed on 10/04/2024 that two patients experienced postoperative incision infections.This information was obtained from a clinical study and reported through clinical literature.

• Brand Name: STRATAFIX
• Common Device Name: PGA-PCL UNI UD 20CM 2-0 SA
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V; corredor tijuana rosarito 2000; #24702 b ejido francisco villa; tijuana ; MX
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20440598
• Report Number: 3010692967-2024-00088
• Device Sequence Number: 8330611
• Product Code: GAM
• UDI-Device Identifier: 10705031228061
• UDI-Public: 10705031228061
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024
• Report Date (Section F): 10/04/2024

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 Model Number: SXMD1B405
• Was Device Available for Evaluation?: No
• Date Report to Manufacturer: 10/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown