MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2FS-2 2-0 UNDYD MONODERM 14X14

Model Number	SXMD2B406
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/27/2021
Type of Reportable Event	Serious Injury
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.Samples were not available for review.If samples, or additional information becomes available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.Without receiving sterile devices from the same lot to tensile test, receiving photo¿s of the surgical site or receiving detailed information regarding the pre-operative preparation of the devices, placement of the device in the tissue, method utilized to secure the device in the tissue as stated in the ifu, surgeon¿s experience and/or technique, the patient¿s health status and specifics, or quality of the tissue, a definitive root cause for the reported event cannot be confirmed with certainty.As stated in the ifu for the devices, ¿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 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.
Event or Problem Description
A pregnant woman underwent cesarean section with transverse incision at lower uterine segment under spinal epidural anesthesia on (b)(6) 2021.The operation went smoothly.The barbed suture was used for sewing the skin layer.The patient was in good condition on the same day.The patient had no other abnormal reactions.The next day on (b)(6) 2021, patrol found barbed suture broke and skin incisions cracked, the patient was immediately placed in the operating room for local anesthesia, the skin incision was resewed and the process was smooth, and the patient did not see other abnormal reactions.The broken suture will be sent back, and the hospital requires to provide the product test report as soon as possible.

• Brand Name: STRATAFIX
• Common Device Name: 2FS-2 2-0 UNDYD MONODERM 14X14
• 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): LUIS JAUREGUI JAUREGUI OROZCO; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 13026801
• Report Number: 3010692967-2021-00056
• Device Sequence Number: 5441514
• Product Code: GAM
• UDI-Device Identifier: 20705031208060
• UDI-Public: (01)20705031208060(20)12(17)260131(10)AAHH286
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2021
• Report Date (Section F): 12/03/2021

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 Expiration Date: 03/01/2026
• Device Model Number: SXMD2B406
• Device Lot Number: AAHH286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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
• Patient Sex: Female