MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; HIMAX

Model Number	7118-1818KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3020584246-2022-00038
• Device Sequence Number: 7848955
• Product Code: JDR
• UDI-Device Identifier: 00815432023363
• UDI-Public: 00815432023363
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7118-1818KT
• Device Lot Number: 300196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male