MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; HIMAX

Model Number 7118-1818-C

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

The surgeon performed a lapidus procedure using dynaforce clip, plate and screws on (b)(6) 2019.The patient returned for follow-up (b)(6) 2020.The follow-up x-ray revealed that the leg of the clip was broken.The surgeon reports that the patient was non-complaint with follow-up instructions that may have contributed to the failure.The patient is asymptomatic.The surgeon may complete a revision surgery in summer 2020.

Manufacturer Narrative

The lot history records of the sterile and individual component parts were reviewed in their entirety during the investigation.These records included quality inspection records, component inspection records, component print specification, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of conformance.No non-conformances were found in any records that were reviewed that would have contributed to the device failure.Description: part number, lot number, himax c sterile, 7118-1818-c, 500519, himax c - component, 240008c-ep, 103267.

• Brand Name: DYNAFORCE
• Type of Device: HIMAX
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501816
• MDR Text Key: 301079324
• Report Number: 3020584246-2022-00043
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00815432026272
• UDI-Public: 00815432026272
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: 7118-1818-C
• Device Catalogue Number: 7118-1818-C
• Device Lot Number: 500519
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2018
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Female