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

Model Number	SXMD1B406
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that there was a problem with the needle pulling free from the suture during the surgery.Changed to another one to complete the surgery without incident.There was no report of patient injury, delay or intervention.Additional information received from our distributor on (b)(6) 2023 indicated during the process of repairing a gastric perforation for the patient, the needle broke in the patient''s stomach.Due to timely treatment by the doctor, the remaining needle was completely removed from the stomach without injury or delay.".
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.The needle component is supplied by ethicon.A review of the broken needle will be performed by a 3rd party laboratory.No samples, or photographs of the broken device were provided for review.No third party evaluation report was received to date.If samples, photos or the report becomes available at a later time, they will be reviewed, and the results will be included in the file.A follow-up report will be submitted at that time.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps or some type of 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.The stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.Without reviewing the actual broken needle, testing sterile devices from the same finished good lot, receiving the results of the third party evaluation of the needle component or receiving details regarding the preoperative preparation of the device, tools utilized to grasp the needle component or tools utilized in conjunction with the medical device (robotics), the size trocar used compared to the size needle on the device, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Common Device Name: SH 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; 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: 17892728
• Report Number: 3010692967-2023-00049
• Device Sequence Number: 7389608
• Product Code: GAM
• UDI-Device Identifier: 10705031228030
• UDI-Public: (01)10705031228030(20)12(17)271031(10)CB29WGB
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2023
• Report Date (Section F): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SXMD1B406
• Device Lot Number: CB29WGB
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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 Sex: Unknown