MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; 2MH -0- PDO 36 X 36

Model Number	SXPD2B412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Genital Bleeding (4507)
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the reporter the patient was diagnosed with a spread of sutures during the check-up.The patient needed to re-sew.Even though requested it is unknown when index surgical procedure occurred.At this time no root cause can be identified.
Additional Manufacturer Narrative
A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.No sterile samples were returned for review.If 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.Per the ifu, ¿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.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¿.Without receiving sterile samples from the same 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 or quality of the tissue where material was placed, method of anchoring the device in the tissue, post-operative activities or 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.
Additional Manufacturer Narrative
Batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.Only the foil package for the above issue was returned therefore the root cause cannot be determined.The actual device was not returned for analysis.Per the ifu, ¿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.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¿.Without receiving actual device and/or sterile samples from the same 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, post-operative activities or 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: 2MH -0- 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
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 19989949
• Report Number: 3010692967-2024-00064
• Device Sequence Number: 20968332
• Product Code: NEW
• UDI-Device Identifier: 10705031208001
• UDI-Public: (01)10705031208001(20)16(17)280229(10)D309QAZ
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: SXPD2B412
• Device Lot Number: D309QAZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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