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	07/06/2022
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 process.The needle is an ethicon supplied component.The exact device was not returned for review.Samples from the same lot were not available for review.The third party evaluation report has not been received to date.If samples or the report become available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, 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 receiving ethicon¿s third party analysis, testing sterile devices from the same finished good lot, reviewing magnified photos of the broken device or receiving details regarding the tools utilized to grasp the needle component/size of trocar utilized, procedure performed, details of intervention provided, or the surgeon¿s technique a definitive root cause cannot be determined at this time.
Event or Problem Description
It was reported that the needle broke when sewing during hysterectomy surgery.Changed to another one to complete the surgery.There is no report of patient injury.Additional information provided by our distributor indicated the needle fell into the patient's body and had to be retrieved without incident.No second surgery was performed.The patient was reported to be in good condition.
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.The needle is an ethicon component.The actual device was returned to ethicon¿s third party review and analysis.Included in the third party analysis were photo¿s of the actual device.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.Fractographic evaluation a scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The sample was ultrasonically cleaned with a solution of tergazyme for 5-min, a heated solution of alconox for 10-min, tergazyme for an additional 5-min, deionized water for two minutes and acetone for five minutes.The cleaning process was repeated to remove adherent particles from the fracture surface.Some debris remained on the surface; however additional cleaning was not performed to preserve the fine fractographic features.The specimen was then air-dried and stored until analysis.A profile and top view of the needle fracture was reviewed.The fracture surfaces were examined in multiple locations to determine the fracture mode.The fracture surface contained predominantly microvoid coalescence (mvc), evidence of a ductile fracture mode.Mechanical damage in the form of indents and scratches were observed coincidental to the fracture.Conclusions and discussion the evaluation of pc-(b)(4) (corza complaint (b)(4)) revealed the fracture was composed predominantly of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.

• 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; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 02090 ; MX 02090
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, PA 02090
• MDR Report Key: 15234963
• Report Number: 3010692967-2022-00032
• Device Sequence Number: 17810477
• Product Code: NEW
• UDI-Device Identifier: 10705031227941
• UDI-Public: (01)10705031227941(20)12(17)270131(10)C224PBA
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022
• Report Date (Section F): 07/27/2022

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 Model Number: SXPD1B401
• Device Lot Number: C224PBA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2022
• 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
• Patient Sex: Unknown