MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; 2CT-1 #2 PDO 24 X 24

Model Number	SXPD2B402
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
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 in-process, or final inspection process.Sterile samples were not available for testing / review.Retained samples were not available for review.No photos of the surgical site were provided for review, if samples, photos or additional information become available at a later date, the samples, photos or information will be reviewed and results will added to the file.A follow-up report will be submitted.The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.It's also possible the devices are being grasped with surgical instruments damaging the suture allowing the suture to break during use.The precautions section of the ifu for the stratafix device states, ¿the tying of knots on the barbed section of material will damage the barbs and potentially reduce their effectiveness.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.¿ pdo 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 lots were reviewed and meet all requirements.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.To avoid damaging needle points, swage areas and attachments, 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 devices from this same lot to review/test or receiving detailed information regarding the pre-operative preparation of the devices, tools utilized to grasp the devices, the method utilized to anchor the device in the tissue, the patient¿s health status and quality of the tissue, or the surgeon¿s experience and/or technique, a definitive root cause for the reported event cannot be confirmed with certainty.
Event or Problem Description
The doctor used suture to repair and suture the uterus during the surgery.During the knotting process, the suture broke, causing wastage of consumables and delaying the surgery time.There was also a risk of the needle falling into the patient's pelvic cavity.No additional information was provided at this time.
Additional Manufacturer Narrative
The purpose of this report is to correct the date of report in b4 to 07/02/2024 in place of 06/27/2024.

• Brand Name: STRATAFIX
• Common Device Name: 2CT-1 #2 PDO 24 X 24
• 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: 19659338
• Report Number: 3010692967-2024-00042
• Device Sequence Number: 15165764
• Product Code: NEW
• UDI-Device Identifier: 10705031207882
• UDI-Public: (01)10705031207882(20)12(17)271231(10)D116QTK
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024
• Report Date (Section F): 06/10/2024

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: SXPD2B402
• Device Lot Number: D116QTK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 06/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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: Other; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female