MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; HIMAX

Model Number 7118-1818KT

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

Part number lot number description 7118-1818kt.300196.Himax 18mm x 18mm x 18mm, sterile 240008ep 104038.Component, himax 18mm x 18mm x 18mm.8-digit part number lot records include packaging work routers, label masters, sterile pack-out prints, implant printers, work order, work order pick list, pyrogenicity testing and sterilization certificate.No nonconformances were found in any of these records that were reviewed.The analysis of the manufacturing documents for these lots demonstrate that the raw material and the manufacturing process were conforming.There were no process deviations identified for these lots.No evidence was found in these manufacturing records that suggest that the device did not meet the approved product specifications prior to distribution.

Event Description

Doctor performed an mtp fusion surgery on (b)(6) 2019 that was a revision to another doctor's bunion surgery done on the same patient.At some point post-surgery one of the legs of the clip broke.No revision as patient is asymptomatic.

• 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: 15501811
• MDR Text Key: 306328665
• Report Number: 3020584246-2022-00038
• 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
• 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 Model Number: 7118-1818KT
• Device Lot Number: 300196
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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: 62 YR
• Patient Sex: Male