MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2RB-1 2-0 U MND 16X16 13MM LDR

Model Number	SXMD2B402
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Our distributor reported: the clinician stated that the thread does not have the same tightness as always.The suture releases.The needle detached from the thread.The procedure was completed successfully.On 09/25/2023 information was received which indicated the needle fell into the patient, but it was retrieved.In the same laparoscopic procedure.The broken piece inside the patient was located with the laparoscopic camera.The patient is reported to be in good condition.
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.A potential root cause for a needle detaching when slightly tugged during a procedure could be that the suture was not fully inserted within the end of the needle during the manufacturing process.It¿s also possible the device(s) are being grasped on or near the swaged end, damaging the suture, allowing it to break free from the needle component.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, details of the procedure performed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Additional Manufacturer Narrative
A sterile device from the same finished good lot was returned by the end user for visual review and pull testing.No defects were observed on the packages or the device(s).The devices met all specifications including the usp needle pull requirements 2-0 monoderm¿ device.

• Brand Name: STRATAFIX
• Common Device Name: 2RB-1 2-0 U MND 16X16 13MM LDR
• 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: 17842257
• Report Number: 3010692967-2023-00046
• Device Sequence Number: 11874681
• Product Code: GAM
• UDI-Device Identifier: 10705031208094
• UDI-Public: (01)10705031208094(20)17(17)270930(10)CA18KWT
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023
• Report Date (Section F): 09/25/2023

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: SXMD2B402
• Device Lot Number: CA18KWT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown