MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; SH-1 0 PPN 30CM

Model Number	SXPL1B400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was not provided so a batch review of the finished good lot and components could not be reviewed at this time sterile samples were not available for testing / review.Retained samples were not available for review.No photos of the surgical site were provided for review, if samples, photos or additional information become available at a later date, the samples, photos or information will be reviewed and results will added to the file.A follow-up report will be submitted.The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.It's also possible the devices are being grasped with surgical instruments damaging the suture allowing the suture to break during use.Pga/pcl suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Surgical specialties documents the exposure time throughout the inspection and manufacturing processes to prevent over-exposure prior to packaging the devices.The exposure time for this particular lot was reviewed and the exposure time meets the current criteria.The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points, swage areas and attachments, 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¿.Without receiving sterile devices from this same lot to review/test or receiving detailed information regarding the pre-operative preparation of the devices, tools utilized to grasp the devices, the method utilized to anchor the device in the tissue, the patient¿s health status and quality of the tissue, or the surgeon¿s experience and/or technique, a definitive root cause for the reported event cannot be confirmed with certainty.
Event or Problem Description
During a surgical procedure it was reported that, when the doctor passes the point at the sub-axillary level; the suture was damaged, leaving it in the middle strand (stratafix 2/0 suture of 30cm).The surgery was not delayed.It is not known how the fragments were removed.The surgery was completed successfully.
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.

• Brand Name: STRATAFIX
• Common Device Name: SH-1 0 PPN 30CM
• 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: 19082441
• Report Number: 3010692967-2024-00023
• Device Sequence Number: 20773359
• Product Code: GAM
• UDI-Device Identifier: 10705031228122
• UDI-Public: (01)10705031228122(20)16(17)280731(10)D831HDG
• 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: Study,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024
• Report Date (Section F): 03/20/2024

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 Model Number: SXPL1B400
• Device Lot Number: D831HDG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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