MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; SH 2-0 MONODERM 20CM

Model Number	SXMD1B405
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No samples were returned for testing or review.No retained samples are available for testing/review.If samples become available at a later time the devices will be evaluated and the results will be included in a follow-up report.A review of the device history records for the finished good lot and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.The bending, fracturing, breaking or needle detaching from the suture can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.Without reviewing the actual needle, receiving magnified photos of the device, testing sterile devices from the same finished good lot or receiving details regarding the tools utilized to grasp the needle component, procedure performed or the surgeon¿s technique a definitive root cause cannot be determined at this time.
Event or Problem Description
Our distributor reported that the patient underwent gastric stromal tumor surgery.When sewing the common surgical incision of gastrointestinal tissue, the needle pulled off the suture.X-ray's were used to look for the needle but it could not be found.A ct scan was used to remove the needle.The surgery was delayed for about 6 hours.The patient is stable now.

• Brand Name: STRATAFIX SUTURE
• Common Device Name: SH 2-0 MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana ; MX
• MDR Report Key: 12287582
• Report Number: 3010692967-2021-00027
• Device Sequence Number: 16926661
• Product Code: GAM
• UDI-Device Identifier: 10705031228061
• UDI-Public: (01)10705031228061(20)12(17)250831(10)AAGO767
• Combination Product (Y/N): Y
• 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: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021
• Report Date (Section F): 07/26/2021

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: 09/03/2025
• Device Model Number: SXMD1B405
• Device Lot Number: AAGO767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention