MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 20S-8 #2 PDO 36 X 36

Model Number	SXPD2B202
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
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, in-process, or final inspection.The needle component is supplied by ethicon.A review of the broken needle will be performed by a 3rd party laboratory.No samples, or photographs of the broken device were provided for review.No third party evaluation report was received to date.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.A follow-up report will be submitted at that time.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.A report of a needle detaching during use could be due to the suture material not being placed deep enough within the needle hole during the manufacturing process.It¿s also possible excessive force is utilized when removing the device from the packaging or during the procedure, exceeding the strength of the attachment, allowing the needle to pull free from the suture or the devices are being grasped on or near the swaged end of the needle, damaging the suture, allowing the needle to break free from the suture during use.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 detached/broken 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 or tools utilized in conjunction with the medical device (robotics), procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The health authority reported to our distributor, after removing the uterine lesion during the surgery, the doctor needed to use suture to suture the uterus.During the suturing process, the needle broke during the process of removing the needle from the uterine wound, causing the problem of pulling off suture needle.The doctor promptly discovered and removed the needle, and continued to complete the operation after replacing it.This event increased the surgical time and increased the risk of infection.

• Brand Name: STRATAFIX
• Common Device Name: 20S-8 #2 PDO 36 X 36
• 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: 17836454
• Report Number: 3010692967-2023-00042
• Device Sequence Number: 7456934
• Product Code: NEW
• UDI-Device Identifier: 10705031207882
• UDI-Public: (01)10705031207882(20)12(17)270930(10)CA27NMV
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2023
• Report Date (Section F): 09/05/2023

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 Model Number: SXPD2B202
• Device Lot Number: CA27NMV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2022
• 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: Required Intervention; Other
• Patient Age: 35 YR
• Patient Sex: Female