MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; MONODERM

Model Number SXMD1B102

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Discharge (2225)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

To date there have been no used or sterile samples available for visual evaluation testing.There are no retained samples to do testing.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.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.A review of the device history records for the finished good lots, did not identify any quality issues during the manufacturing, in-process or final inspection processes.

Event Description

It is being reported an orthopedic surgeon mentioned he noticed 3 consecutive cases of stratafix spiral pgl-pcl 2-0 breaking.The surgeon noticed wound discharge and superficial wound gaping on the patient from cases done on the 9th & 10th may.His layers of closure is usually: joint capsule: v-loc size 1 x 2 pcs subcut fat to dermis layer.There were not additional procedures, steri-stripes on the skin were used.No other information is available at this time.

• Brand Name: STRATAFIX
• Type of Device: MONODERM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; rd. 495 montana industrial pk; aguadilla PR 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8700183
• MDR Text Key: 148059632
• Report Number: 3010692967-2019-00018
• 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,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SXMD1B102
• Device Lot Number: MDVR550
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 06/03/2019
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1