MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS, LLC CROSSCLIP/MOTOCLIP SUPERELASTIC FIXATION SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE BONE STAPLE

Model Number 1442-2020

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

At time of original surgery, surgeon implanted 7 clips, 2 plates and 1 screw.At time of revision surgery, 4 clips were found broken.Devices were not returned, so therefore we are unable to properly identify the size and lot number of the failed components.Based on xrays, we have determined one 18mm x 14mm x 14mm clip was broke and 3 20mm x 20mm x 20mm clips were broke.There were no broken plates or screws per our investigation, we believe the hardware failure is due to patient conditions and use of product in a contraindicated condition.Failure of hardware is not unexpected in these sort of situations.Device not returned to manufacturer.

Event Description

Original surgery date was (b)(6) 2016.Revision surgery performed on (b)(6) 2017 due to collapsed foot and broken hardware/clips.

• Brand Name: CROSSCLIP/MOTOCLIP SUPERELASTIC FIXATION SYSTEM
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE BONE STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS, LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer (Section G): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer Contact: vernon hartdegen ; 6055 primacy parkway; suite 140; memphis, TN 38119 ; 9012248406
• MDR Report Key: 6591095
• MDR Text Key: 75962752
• Report Number: 3011421599-2017-00006
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1442-2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 40 YR