MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; CT-1 0 PDO 20CM

Model Number	SXPD1B400
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Retroperitoneal Hemorrhage (4483)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the health authority to our distributor the suture was broken when the surgeon attempted to sew vaginal stump.Resulting in residual sutures in the patient's body.The ruptured sutures were removed, changed another one to complete the surgery, increasing tissue oozing and prolonging the surgical time.
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.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 revised response will be forwarded to you at that time.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 in the ifu for the device states ¿the stratafix¿ pdo device contains a loop end and barbs to anchor tissues and does not require knots to approximate opposing edges of a wound.Tying of knots on the barbed section of the material will damage the barbs and potentially reduce their effectiveness.For the device to function properly, the stratafix¿ spiral pdo device must first be anchored in the tissue by the deployment of the loop around robust tissue, then with the other subsequently engaged in the tissue by the barbs.Additionally, when completing placement of the barbed segment, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the stratafix¿ spiral pdo device in place.Care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holder and forceps¿.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.

• Brand Name: STRATAFIX
• Common Device Name: CT-1 0 PDO 20CM
• 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: 17235152
• Report Number: 3010692967-2023-00033
• Device Sequence Number: 5806433
• Product Code: NEW
• UDI-Device Identifier: 10705031227958
• UDI-Public: (01)10705031227958(20)12(17)270430(10)C509CPE
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023
• Report Date (Section F): 06/06/2023

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: SXPD1B400
• Device Lot Number: C509CPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female