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	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As per distributor the needle broke during the surgical procedure.The broken needle was retrieved from the patient.
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.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks as indicated in the precautions section of the instruction for use.The actual device was not available for review.Without receiving sterile devices from the same finished the ethicon third party evaluation of the needle component or receiving details regarding the preoperative preparation of the device, tools utilized to grasp the needle component, 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
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20695493
• Report Number: 3010692967-2024-00101
• Device Sequence Number: 3756890
• Product Code: GAM
• UDI-Device Identifier: 10705031228030
• UDI-Public: 10705031228030
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: DB08ROE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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 Sex: Unknown