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

Model Number SXPD2B405

Device Problem Device Slipped (1584)

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

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records including sterility records for the finished good lots, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes.There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria.Sterile samples from the reported lot were received and reviewed for barb placement and depth by our quality engineer.No defects were observed and barbs were obvious on all of the devices.The devices were designed according to the current specification for item sxpd2b405.The samples met all usp and surgical specialties (b)(4) requirements.The sterilization certificate for this particular lot was reviewed in detail and the method and all results meet the required guidelines.Samples from the reported lot were received, evaluated and visually reviewed by our quality engineer.No defects were observed on the device.The packages remained free from any noticeable damage and all seals were intact.Based on this; we can conclude that the reported device was sterilized and met all usp and surgical specialties (b)(4) requirements.Without receiving pertinent details regarding the pre-operative preparation of the device, surgeon's technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, actual results of the culture or blood screen, type of infection/reaction confirmed and type of antibiotics/ medications prescribed to treat, a definitive root cause cannot be determined at this time.

Event Description

During the procedure the surgeon felt on the suture that it doesn''t stay on the place, but it slides like there is no anchors.Follow-up information on 4/5/2019 indicated the patient had another operation and is taking antibiotics.No other information is available at this time, such as if the wound dehisce or there was an infection.

Event Description

During the procedure the surgeon felt that the suture wouldn''t stay in place, but it slides like there were no anchors (barbs).The surgeon finished procedure successfully with another classic suture, not stratafix.No additional information on the product or initial procedure was disclosed.Additional information received mentioned antibiotics and the patient requiring another procedure without pertinent details.

Manufacturer Narrative

From the information received, it is not clear what type of device was used to complete the procedure other than it was not a stratafix device.There is no additional details on the post-op procedure or what type antibiotics were prescribed.

• Brand Name: STRATAFIX
• Type of Device: STRAFIX PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702 b ejido francsico villa; tijuana 22235
• MDR Report Key: 8535724
• MDR Text Key: 142736073
• Report Number: 3010692967-2019-00013
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: SXPD2B405
• Device Lot Number: AACW324
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 03/06/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other