MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; HIMAX

Model Number	7115-1515KT
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, part number, lot number.Himax 15mm x 15mm x 15mm - sterile kit, 7115-1515kt, 300074.Himax 15mm x 15mm x 15mm - component, 240004ep, 103082.
Event or Problem Description
Doctor reports that on (b)(6) 2019 he performed a 1st, 2nd, and 3rd tarso-metatarsal fusion surgery using crossroads staples for the 2nd and 3rd tmt fusions.He says that at some point post-surgery the proximal staple leg in the 3rd tmt joint broke.Doctor reports that the patient is a smoker and is also non-compliant with regards to weightbearing.However, he says on the oblique x-ray provided that the joints appear to be healing well and fusing.

• 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: 15501686
• Report Number: 3020584246-2022-00034
• Device Sequence Number: 7755393
• Product Code: JDR
• UDI-Device Identifier: 00815432023325
• UDI-Public: 00815432023325
• 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 Expiration Date: 12/04/2020
• Device Model Number: 7115-1515KT
• Device Lot Number: 300074
• 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: 11/30/2018
• 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: 49 YR
• Patient Sex: Female