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

Model Number SXPD2B202

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 06/16/2019

Event Type  Injury  

Manufacturer Narrative

To date a sample has not been returned for evaluation and testing.A lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue.A definitive root cause for the reported events of dehiscence(s) cannot be confirmed with certainty.Wound dehiscence is one of the most common complications of surgical wounds, involving the opening of the surgical incision.There are many causes that can result in the wound opening or sutures failing during or post-operative a procedure such as: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise, heavy lifting, recurrent vomiting, coughing or an improper diet that leads to constipation.

Event Description

It was reported by our affiliate that a patient returned to emergency room post operative on (b)(6) 2019 with wound dehiscence.The wound was dressed and the patient was transported to the facility where the total knee procedure was performed on (b)(6) 2019.There the wound was re-closed.No additional information.

• 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: 8776040
• MDR Text Key: 150560304
• Report Number: 3010692967-2019-00021
• Device Sequence Number: 1
• Product Code: GAB
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/10/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B202
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 06/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention