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

Model Number	SXMD1B405
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The needle broke during the tumor surgery/blood vessel blockage.The needle fell into the patient's body and could not be found for observation.Because of emergency, the tumor could only be sutured, the blockage was released, and the search continued, and finally the needle was found in the patient's body.At present, the patient's vital signs are stable.Procedure: laparoscopic resection of right renal tumor under general anesthesia.
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 process.The needle is an ethicon supplied component.A retained sample from the device history record was visually reviewed and functionally tested.No defects or abnormalities were observed on the suture/needle.The sample met the current specification including the usp needle pull and tensile strength requirements for a 2-0 monoderm¿ device.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 submitted at that time.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 report, 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.

• 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; 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: 15584658
• Report Number: 3010692967-2022-00045
• Device Sequence Number: 7142454
• Product Code: GAM
• UDI-Device Identifier: 10705031228061
• UDI-Public: (01)10705031228061(20)12917)261130(10)BC09BMC
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022
• Report Date (Section F): 10/04/2022

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: SXMD1B405
• Device Lot Number: BC09BMC
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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
• Patient Age: 26 YR
• Patient Sex: Female