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

Model Number SXPD1B401

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

No samples were returned for testing or review.No retained samples are available for testing/review.If samples become available at a later time the devices will be evaluated and the results will be included in the file.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.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 component is supplied by (b)(4).

Event Description

Our affiliate is reporting the needle broke during an endoscopic radical prostatectomy procedure.The changed to an open procedure to remove the broken needle piece.The surgery was delayed five (5) hours.

• Brand Name: STRATAFIX
• Type of Device: CT-1 0 PDO 30CM SUTURE NEEDLE
• 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 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 9356413
• MDR Text Key: 207425727
• Report Number: 3010692967-2019-00036
• 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: 01/01/2005,11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: SXPD1B401
• Device Lot Number: MDWT860
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 11/07/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention