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

Catalog Number 7118-1414KT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

This mdr was identified as part of complaint file remediation project.Non-union was identified 2 months post-op.The fusion site did not properly fuse/heal.None of the implanted hardware mechanically failed.The hardware was removed during a revision surgery and no additional hardware was implanted.Patient was non-compliant with post-op protocol.The patient is also diabetic and neuropathic.The hardware was implanted on (b)(6) 2018 and removed on (b)(6) 2018.Based on the investigation results, no defects were found with the crossroads implants that were used.The device failure category is currently unknown.It is unknown if the patient followed post-operative instructions including the importance of immobilization of the treatment site using routine methods be maintained until bone healing has occurred.Additional hardware used with the component previously listed: dynaforce mpj plate 5degree valgus, 0degree dorsiflexion, 18mm, sterile packaged part number 7r50-0018 lot number 500190.

Event Description

Two (2) months post-op, a non-union was identified.A revision surgery was performed to remove the hardware.No additional hardware was replaced.Original hardware was not broken.

• 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: 9410358
• MDR Text Key: 169408415
• Report Number: 3011421599-2019-00020
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432023356
• UDI-Public: 00815432023356
• Combination Product (y/n): N
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7118-1414KT
• Device Lot Number: 500162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2018
• 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