MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; HIMAX

Model Number	7125-2222KT
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
The lot history records of the following sterile implants and individual component parts were reviewed in their entirety during the investigation.These records include quality inspection procedures, component inspection records, component print specifications, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of compliance.No non-conformances were found in any of these records that were reviewed.Description: himax 25mm x 22mm x 22mm - sterile kit, part number: 7125-2222kt, lot number: 300005; himax 25mm x 22mm x 22mm - component, 240012ep, 102994; himax 25mm x 22mm x 22mm - sterile kit, 7125-2222kt, 500165; himax 25mm x 22mm x 22mm - component, 240012ep, 102531; himax 25mm x 22mm x 22mm - component, 240012, 102469; himax 25mm x 22mm x 22mm - sterile kit, 7125-2222, 500139; himax 25mm x 22mm x 22mm - component, 240012ep, 102469; himax 25mm x 22mm x 22mm - component, 240012, 102469;.
Event or Problem Description
Doctor reports that on (b)(6) 2018 he performed a midfoot and subtalar fusion case.He used crossroads staples in the midfoot to fuse the medial and intermediate cuneiforms to a navicular graft from the iliac crest that was harvested in the same surgery.This patient had mueller weiss syndrome which is an adult onset osteonecrosis of the tarsal navicular.At some point post-operation one of the clip legs broke in the patient.Doctor says the bones eventually fused even though one of the clip legs was broken.

• 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: 15501693
• Report Number: 3020584246-2022-00033
• Device Sequence Number: 7755398
• Product Code: JDR
• UDI-Device Identifier: 00815432023400
• UDI-Public: 00815432023400
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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 Expiration Date: 05/31/2020
• Device Model Number: 7125-2222KT
• Device Lot Number: 300005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2018
• 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: 63 YR
• Patient Sex: Female