MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SXPD2B405 2 PDO

Model Number SXPD2B405

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Method-the actual device was discarded by the end user. However, sterile samples from the same finished good lot were returned for review/testing. Results-relevant portions of he device history records were reviewed. The product from the finished good lot and all component lots met current usp and surgical specialties requirements throughout the incoming, manufacturing, in-process and final inspection processes. The returned samples were tested and met the acceptance criteria. Dehiscence is a known risk with and suture material. A definitive root cause for the post-operative dehiscence cannot be determined at this time.

Event Description

It was reported by the customer that five patients returned to the same doctor complaining of dehiscence at the suture site after unknown orthopedic procedures. No patient specific information was disclosed. One patient returned less than six weeks with complete dehiscence of the surgical incision.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX SXPD2B405 2 PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 6956472
• MDR Text Key: 89565901
• Report Number: 3010692967-2017-00006
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2021
• Device Model Number: SXPD2B405
• Device Catalogue Number: SXPD2B405
• Device Lot Number: MBJW300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/17/2017 Patient Sequence Number: 1