MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; SH 2-0 MONODERM 20CM

Model Number	SXMD1B405
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2024 that a needle broke intraoperatively.The needle was successfully removed from the site and no patient injury was reported; however, the failure resulted in a significant procedural delay and intervention was required.
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 (b)(4).The actual device was not available for review.No third-party evaluation report was received for the broken needle.If samples, photos or the report becomes available at a later time, they will be reviewed, and the results will be included in the file.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, 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 stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.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.The precautions section of the ifu for the stratafix device states, ¿the tying of knots on the barbed section of material will damage the barbs and potentially reduce their effectiveness.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.¿ pdo suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Without reviewing the actual broken suture and needle, testing sterile devices from the same finished good lot, receiving the results of the 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 2-0 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: 20267156
• Report Number: 3010692967-2024-00077
• Device Sequence Number: 7212331
• Product Code: GAM
• UDI-Device Identifier: 20705031228068
• UDI-Public: (01)20705031228068(20)12(17)281130(10)DB23ZUE
• 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,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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: SXMD1B405
• Device Lot Number: DB23ZUE
• 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: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• 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 Age: 71 YR
• Patient Sex: Male