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

Model Number	SXPD1B401
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This case was reported from the health authority to our distributor.After the myoma was removed during the surgery , the needle tip broke when the doctor sewed the uterine wound.Through repeated inspection of abdominal cavity and pelvic cavity, no needle tip of about 2mm was found.The bedside abdominal plain film examination was performed, which indicated that "scattered intestinal gas and contents can be seen in the abdomen, no intestinal dilatation or liquid level is found, and the abdominal fat lines on both sides are clear.No high-density metal foreign body shadow is found in the abdomen." rinse and aspirate again and again, and check the aspirated liquid, but the dropped needle tip was not found.After the surgery , the patient woke up without complaint.The intestinal exhaust was smooth after the surgery.The patient was discharged on the third day after the surgery , and the outpatient department was ordered to conduct regular reexamination.
Additional Manufacturer Narrative
A review of the device history records for the finished good lot and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.The needle is an ethicon supplied component.No samples or photographs of the broken device were returned for evaluation.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, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• 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 ; MX
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 15379867
• Report Number: 3010692967-2022-00036
• Device Sequence Number: 5796910
• Product Code: NEW
• UDI-Device Identifier: 20705031227948
• UDI-Public: (01)20705031227948(20)12(17)260630(10)AAIB093
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2022
• Report Date (Section F): 09/01/2022

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 Expiration Date: 06/30/2026
• Device Model Number: SXPD1B401
• Device Lot Number: AAIB093
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2022
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2021
• 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: 39 YR
• Patient Sex: Female