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

Model Number SXPD1B401

Device Problems Break (1069); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2022

Event Type  malfunction  

Event Description

The health authority reported to our distributor that the needle broke when sewing in surgery.Searched for the needle tip immediately.Changed to another one to complete the surgery.No additional information was provided.

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 to one-half 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, details regarding the results of the search for the needle or the surgeon¿s technique a definitive root cause cannot be determined at this time.

Manufacturer Narrative

We received additional information from our distributor which indicated the needle fell into the patient and was retrieved immediately.A c-arm was not used to look for the needle there was no additional information on the patient¿s condition.

• Brand Name: STRATAFIX
• Type of Device: 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 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 14596916
• MDR Text Key: 301031820
• Report Number: 3010692967-2022-00021
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Public: (01)2070503122794B(20)12(17)260831(10)B916KFS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022,06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPD1B401
• Device Lot Number: B916KFS
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other