MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2MO-4 #2 PDO 36 X 36

Model Number	SXPD2B400
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.There were no retained or sterile samples available for review/testing.No photos were received for review.If samples or photos become available at a later time, they will be evaluated and the results will be included in the file.A revised response will be forwarded at that time.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, over-tightened 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.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.Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin.That is why it is not uncommon for spitting sutures to occur.Without receiving details or photographs of the incision/post-operative condition, receiving sterile devices from the same lot to test or receiving pertinent details regarding the patient's health history, past reactions to suture material or medications, relevant culture results, condition of the tissue where the device was placed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The health authority reported to our distributor.The doctor sutured the patient's wound with suture, and the patient was discharged after recovering well after surgery.On the 47th day after surgery, the patient complained of redness and swelling in the wound, as well as discharge of secretions.During the doctor's examination of the wound, it was found that the suture was not absorbed.The doctor immediately changed the dressing and removed the suture, and provided relevant health education to the patient before instructing them to continue observing the condition.

• Brand Name: STRATAFIX
• Common Device Name: 2MO-4 #2 PDO 36 X 36
• 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 MA 02090
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 17981995
• Report Number: 3010692967-2023-00051
• Device Sequence Number: 3518169
• Product Code: NEW
• UDI-Device Identifier: 10705031207974
• UDI-Public: (01)10705031207974(20)12(17)270531(10)C629MTZ
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023
• Report Date (Section F): 10/12/2023

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: SXPD2B400
• Device Lot Number: C629MTZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2023
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 10/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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 Age: 68 YR
• Patient Sex: Female