MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2CT-1 -2- CL PPN 24X24

Model Number	SXPL2B400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during an unknown procedure that they opened the first packet and said the needle popped off and they opened another one and the needle popped off inside the patient.They were able to retrieved from the patient.Another like device was used to complete the procedure.There were no adverse consequences for the patient that rep is aware of.No device is available for return.Patient is fine.Procedure was hiatal hernia and needle was retrieved.
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process, or final inspection processes.No additional complaints have been received for this lot.Sterile samples from the reported lot were not returned for visual review and testing.The actual devices or magnified photos were not returned for review.If samples or photos become available at a later time, they will be reviewed and tested and the results will be included in the file.A follow-up report will be submitted at that time.The needle detaching prior to use most likely resulted due to the method utilized to remove the device from the packaging.It is also possible that the devices are being gripped on or near the attachment causing damage to the end of the needle component or snipping the suture which causes the suture to break/snap away from the needle.However, there are numerous other circumstances that can adversely affect the strength and durability of a suture/needle attachment including but not limited to the misalignment of the suture within the end of the needle, the suture material not placed deep enough within the end of the needle and/or if end is not crimped with enough force to form a secure grip onto the suture material.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 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¿.Without reviewing the actual reported device(s), receiving magnified photos of the actual devices, or receiving detailed information regarding the method utilized to remove the device from the packaging, preoperative preparation of the device, tools utilized to grasp the devices, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Additional Manufacturer Narrative
Five (5) sterile devices from the same finished good lot were returned for visual review and pull testing.No defects or abnormalities were observed on the packages or the device(s).The devices met all specifications including the usp needle pull requirements for a pga/pcl device.

• Brand Name: STRATAFIX
• Common Device Name: 2CT-1 -2- CL PPN 24X24
• 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 02090 ; MX 02090
• MDR Report Key: 16500500
• Report Number: 3010692967-2023-00010
• Device Sequence Number: 6297551
• Product Code: GAW
• UDI-Device Identifier: 10705031208209
• UDI-Public: (01)10705031208209(20)36(17)240331(10)AAED207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023
• Report Date (Section F): 02/23/2023

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: 03/31/2024
• Device Model Number: SXPL2B400
• Device Lot Number: AAED207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2023
• Device Age: 46 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2019
• 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: Required Intervention
• Patient Sex: Unknown