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	Material Separation (1562)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
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.The needle is an ethicon device the actual device 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.A broken needle can occur if gripped with needle holders, 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 ¿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 finished good lot number to review manufacturing records and retained samples, receiving the actual reported device for review, receiving magnified photos of the actual device, receiving a third party evaluation report or receiving detailed information regarding the exact failure or event that occurred, preoperative preparation of the device, tools utilized to grasp the device, details of the procedure performed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The distributor report listed the following, loose needle tip at suture point.It also stated the failure as breakage needle.A clear explanation of the failure or event was not disclosed.No other details could be obtained.
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 process.

• 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: 17356850
• Report Number: 3010692967-2023-00034
• Device Sequence Number: 6041457
• Product Code: GAM
• UDI-Device Identifier: 10705031208094
• UDI-Public: (01)10705031208094(20)17(17)270630(10)C728TYM
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023
• Report Date (Section F): 06/16/2023

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: C728TYM
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• 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
• Patient Sex: Unknown