MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRAFIX PDO

Model Number SXPD1B401

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2019

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.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 ethicon.

Event Description

It was reported needle broke at the second stitch in a hystero myomectomy.The broken piece fell inside of patient.X-ray tests to locate and retrieve the broken piece.The procedure was delayed 1 hour.Now patient condition is stable.

• Brand Name: STRATAFIX
• Type of Device: STRAFIX PDO
• 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: 8888122
• MDR Text Key: 207422795
• Report Number: 3010692967-2019-00023
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: SXPD1B401
• Device Lot Number: MDWL510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention