MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; CT-1 0 PDO 30CM

Model Number	SXPD1B401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2023
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, sterilization, in-process, or final inspection.The needle component is supplied by ethicon.A review of the broken needle is normally performed by a 3rd party laboratory.Ethicon informed us that the needle will not be provided to the laboratory for an evaluation.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.Without reviewing the actual 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
This case is from health authority.At 16:15, the patient underwent surgery.During the surgery, while suturing the ovaries with suture, the needle suddenly broke in the abdominal cavity.The surgeon immediately searched for the broken end of the needle and found that the tail end of the broken end was on the surface of the ovaries.The broken end was immediately removed and the needle was intact.Afterwards, another suture of the same type was replaced to suture the ovaries.After the surgery, the patient''s vital signs remained stable and patient was safely returned to the ward after resuscitation.

• Brand Name: STRATAFIX
• Common Device Name: CT-1 0 PDO 30CM
• 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: 17611900
• Report Number: 3010692967-2023-00036
• Device Sequence Number: 12442180
• Product Code: NEW
• UDI-Device Identifier: 10705031227941
• UDI-Public: (01)10705031227941(20)12(17)270930(10)CA10JBP
• 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): 08/24/2023
• Report Date (Section F): 08/18/2023

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: SXPD1B401
• Device Lot Number: CA10JBP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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: 41 YR
• Patient Sex: Female