MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; CT-1 0 PDO 30CM

Model Number SXPD1B401

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

A batch review of the reported lot indicates there were no non-conformances reports issued for the finished goods lot.The product from this finished goods lot and all of the components met surgical specialties requirements throughout the incoming, manufacturing and the final inspection processes.The needle is an ethicon component.No samples were returned for testing or review.There were no retained samples available for testing.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.Without reviewing the actual broken needle, receiving magnified photos of the broken device, testing sterile devices from the same finished good lot or receiving details regarding the tools utilized to grasp the needle component, procedure performed or the surgeon¿s technique a definitive root cause cannot be determined at this time.

Event Description

It was reported to our distributor from the health authority the needle tip was missing after sewing the uterus during a laparoscopic myomectomy.Radiology intraoperative photography was used.The results showed no clear metal density shadow.The tip was not found.Another device was used to complete the surgery without further incident.

• Brand Name: STRATAFIX
• Type of Device: CT-1 0 PDO 30CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; rd. 495 montana industrial pk; aguadilla PR 00605
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; rd 495 montana indusrial park; aguadilla PR 22235
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 9575497
• MDR Text Key: 207427067
• Report Number: 3010692967-2020-00001
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: SXPD1B401
• Device Lot Number: MDWP570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 09/27/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention