MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRATAFIX 2MO-4 #2 PDO 36 X 36

Model Number SXPD2B400

Device Problem Break (1069)

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

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

To date the complaint device has not been returned to surgical specialties for root cause analysis.A review of the device history records by manufacturing for the reported finished good lots, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes.

Event Description

Capsule rupture, in some cases wound dehiscence and leakage.Stratafix breaking during procedure, almost in the middle: infra pathelair/pathelair: 3 times.(knee surgery).

Manufacturer Narrative

Information previously indicated an adverse event however upon receiving follow-up information from the end user/distributor there was no medical safety, patient issue or adverse event for the above issue.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX 2MO-4 #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 8102613
• MDR Text Key: 128390624
• Report Number: 3010692967-2018-00027
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: SXPD2B400
• Device Catalogue Number: SXPD2B400
• Device Lot Number: AACE037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 11/01/2018
• Device Age: 1 YR
• 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): Required Intervention