MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE HIMAX SINGLE PACK IMPLANT 18MM X 20MM X 20MM; STAPLE

Model Number 7118-2020C

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The nitinol clip listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.In addition to the gapping seen on the x-ray, the nitinol implant experiences mechanical failure at some time post-operation.Component implants used in entire construct: motoband cp locking screw 3mm x 20mm, catalog #: 1500-3020, lot #: 500198.Motoband co locking screw 3mm x 16mm, catalog #: 1500-3016, lot #: 500212.Lapidus lz beta 18mm plate, catalog #: 7100-lz18-b, lot#: 500404.

Event Description

Doctor performed a lapidus procedure on (b)(6) 2019.At 8 week follow-up, they noticed some gapping on the plantar side of the first tmt joint, and decided to revise it even though there was partial fusion of the joint.There was also a broken clip leg on the distal side of the joint.The patient was non-compliant and was allegedly walking at week 2.Revision surgery took place on (b)(6) 2019 which removed the original hardware and replaced it with additional hardware.

• Brand Name: DYNAFORCE HIMAX SINGLE PACK IMPLANT 18MM X 20MM X 20MM
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway suite 140; memphis TN 38119
• Manufacturer Contact: vernon hartdegen ; 6055 primacy parkway suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 8571459
• MDR Text Key: 143807417
• Report Number: 3011421599-2019-00003
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K181410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 7118-2020C
• Device Lot Number: 500380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2018
• 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: 57 YR