MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE HIMAX; STAPLE

Catalog Number 7115-1515KT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

This mdr was identified as part of complaint file remediation project.During an unrelated total ankle arthroplasty, the doctor identified a broken motoclip implant.Motoclip implant was removed after the taa was complete.The doctor confirmed that an additional surgery to revise or remove the implant would not have been scheduled proactively separate from the taa.No defects were identified for the implant.The failure catagory is unknown.

Event Description

During an unrelated total ankle arthroplasty, the doctor identified a broken motoclip implant.Motoclip implant was removed after the taa was complete.The doctor confirmed that an additional surgery to revise or remove the implant would not have been scheduled proactively seperate from the taa.

• Brand Name: DYNAFORCE HIMAX
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 9406312
• MDR Text Key: 169013207
• Report Number: 3011421599-2019-00015
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432023325
• UDI-Public: 00815432023325
• Combination Product (y/n): N
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7115-1515KT
• Device Lot Number: 500010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2017
• 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