MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; SH 2-0 MONODERM 20CM

Model Number	SXMD1B405
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor performed the repair of gastric perforation.When finishing sewing, the doctor was about to take out the suture, the problem of pulling off suture needle happened.So there was only the suture without the needle.The needle was not found in the posterior abdomen, and the imaging examination revealed obvious development, and finally found and removed.The surgery was completed.No additional information could be provided.
Additional Manufacturer Narrative
Additional lot reported: lot #: aahn145, p/n:sxmd1b40512, started date: (b)(6) 2021.First operation date: (b)(6) 2021.Udi code: (b)(4).To date, the end user could not confirm which lot was used in the procedure.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 both 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/suture, 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, details of the robotic procedure performed (was a trocar used/correct size used) or the surgeon¿s technique a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Common Device Name: SH 2-0 MONODERM 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; 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: 12847074
• Report Number: 3010692967-2021-00050
• Device Sequence Number: 14565920
• Product Code: GAM
• UDI-Device Identifier: 20705031228068
• UDI-Public: (01)20705031228068(20)12(17)260331(10)AAHN135
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 11/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: SXMD1B405
• Device Lot Number: AANH135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2021
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: Other; Required Intervention
• Patient Age: 58
• Patient Sex: Female