MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE HIMAX STAPLE

Model Number 7120-2020KT

Device Problem Fracture (1260)

Patient Problem Not Applicable (3189)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The nitinol clip listed previously was used in conjunction with the implants listed below.Dynaforce himax 20mm x 20mm x 20mm, catalog # 7120-2020kt, lot #: 300119.

Event Description

A doctor performed a bunion surgery using staples in the 1st tarsometatarsal joint on (b)(6) 2019.At some point post-operation an x-ray shows that one of the staples broke that was used in this joint.The doctor performed a revision surgery to remove the broken hardware on (b)(6) 2019.

• Brand Name: DYNAFORCE HIMAX STAPLE
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 8885616
• MDR Text Key: 154106095
• Report Number: 3011421599-2019-00007
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Model Number: 7120-2020KT
• Device Lot Number: 300111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR