MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; CT-1 0 PDO 30CM

Model Number	SXPD1B401
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/16/2021
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.No samples or photographs were provided for review or testing.If sterile samples or photographs become available at a later time, the devices and/or photos will be reviewed and/or tested and the results will be included in the file.A follow-up report will be submitted.Without receiving samples from the same finished good lot for review or testing or receiving pertinent details regarding patient specific information (ex.Patient health history, past reaction to suture materials, previous history of polyps) and the procedure performed, the surgeon¿s technique, or post-operative events that may have occurred and/or contributed to the events, a definitive root cause cannot be determined at this time.
Event or Problem Description
It was reported that the patient underwent total hysterectomy surgery on (b)(6) 2020, and the device was used to sew the vaginal stump.On (b)(6) 2021, the patient went back to the hospital for reexamination.Through colposcopy, polyps were found on both sides of the vaginal stump, then the polyps were cut off with leep knife under colposcope.The patient is stable now.The customer suspect that the suture rejection is too serious.
Additional Manufacturer Narrative
To clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.¿.

• Brand Name: STRATAFIX SUTURE
• Common Device Name: CT-1 0 PDO 30CM
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• MDR Report Key: 11700326
• Report Number: 3010692967-2021-00016
• Device Sequence Number: 17009536
• Product Code: NEW
• UDI-Device Identifier: 20705031227948
• UDI-Public: (01)20705031227948(20)12(17)250331(10)AAFZ730
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021
• Report Date (Section F): 04/07/2021

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: 04/01/2025
• Device Model Number: SXPD1B401
• Device Lot Number: AAFZ730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1