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

Catalog Number 7120-2020KT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

This mdr was identified as part of complaint file remediation project.Four (4) or 5 months after the initial surgery, the patient was fused so the doctor remove activity restrictions.At 8 month post-op follow up, it was discovered the hardware had failed mechanically but the joint had remained fused.The doctor scheduled hardware but will not replace hardware as the patient has experienced proper fusion.The date of removal surgery was not provided.Based upon investigation results, no defects were identified.Additional hardware used with the component previously listed: dynaforce z alpha 18mm plate part number 7100-za18 lot number 500060.Dynaforce himax single pack implant 18x18x18mm part number 7118-1818 lot number 500138.

Event Description

Nine (9) months post-op broken clip and plate were identified.Revision surgery was scheduled for hardware removal.The doctor confirmed fusion via x-ray and will not place additional hardware after removal.

• 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: 9410446
• MDR Text Key: 169083570
• Report Number: 3011421599-2019-00021
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432023394
• UDI-Public: 00815432023394
• 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: 7120-2020KT
• Device Lot Number: 500120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2017
• 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