MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; PS-1 2-0 MONODERM 30CM

Model Number	SXMD1B100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Our distributor reported that a suture device was used during surgery.Several days after the surgery, the wound was found with suture extrusion.
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lots and raw material components identified no quality issues during the incoming, manufacturing, in-process, or final inspection processes.No sterile devices or the actual device(s) were returned for testing or review.A retained sample was not available for review.If samples become available at a later time, they will be reviewed/tested, and the results will be included in the file.The suture splitting, barbs peeling during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.It¿s also possible the device was not anchored in the tissue per the ifu for the device.Pga suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Surgical specialties documents the exposure time throughout the inspection and manufacturing processes to prevent over-exposure prior to packaging the devices.The exposure time for the reported lot was reviewed and met all current criteria.Adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition, or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, overtightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise and heavy lifting.The warning section in the ifu states, ¿this an absorbable material, the use of supplemental non absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support¿.The ¿precautions¿ section in the ifu for the device states: ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.The surgeon should avoid unnecessary tension, to reduce the occurrence of surface fraying and weakening of the strand.To avoid damaging needle points and swage areas, grasp the needle in an area one third (1/3) to one-half (1/2) of the distance from the swaged end to the point.¿ without receiving sterile samples from the reported lot to review/test, receiving photos of the suture/incision(s) post-operative, or receiving detailed information regarding the pre-operative preparation of the device, procedure(s) performed, placement of the suture in the tissue, patient¿s health history, post-operative activities, receiving details regarding number of days post-operative the event occurred, quality of the tissue where material was placed, events that may have occurred that attributed to the adverse event or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Common Device Name: PS-1 2-0 MONODERM 30CM
• 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
• 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 22235 ; MX 22235
• MDR Report Key: 19820836
• Report Number: 3010692967-2024-00056
• Device Sequence Number: 18316623
• Product Code: GAM
• UDI-Device Identifier: 10705031228047
• UDI-Public: (01)10705031228047(20)12(17)280630(10)D713ELT
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: SXMD1B100
• Device Lot Number: D713ELT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown