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

Catalog Number 7118-1818KT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

This mdr was identified as part of complaint file (b)(6).During a routine follow up visit, it was discovered the clip was broken but the joint had remained fused.The doctor removed the clip (b)(6) 2018 and did not place additional hardware as the patient has experienced proper fusion.Additional hardware used with the component previously listed: dynaforce himax implant kit 18x18x18mm; sterile packaged part number (b)(4); lot number 500058.

Event Description

During a routine follow up visit, it was discovered the clip was broken but the joint had remained fused.The doctor removed the clip (b)(6) 2018 and did not place additional hardware as the patient has experienced proper fusion.

• 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: 9410916
• MDR Text Key: 174626033
• Report Number: 3011421599-2019-00023
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432023363
• UDI-Public: 00815432023363
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7118-1818KT
• Device Lot Number: 500046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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