MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; CROSSCLIP

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
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 ere found in any of these records that were reviewed.Description, part number, lot.Number himaxtm 18mm x 18mm x 18mm - sterile kit, 7118-1818kt, 500124.Himaxtm 18mm x 18mm x 18mm - component, 240008ep, 102475.Himaxtm 18mm x 18mm x 18mm - component pre-ep, 240008, 102468.Himaxtm 18mm x 18mm x 18mm - sterile packed, 7118-1818, 500138.Himaxtm 18mm x 18mm x 18mm - component, 240008, 102529 himaxtm 18mm x 18mm x 18mm - component pre-ep, 240008, 102468.
Event or Problem Description
Doctor reports that on (b)(6) 2018 he performed a 1st, 2nd, and 3rd tmt fusion on a patient.Doctor used a z-alpha plate and screws with a 15mm himax staple for the 1st tmt fusion part of the procedure.For the 2nd and 3rd tmt fusion he used himax 18mm x 18mm x 18mm staples.He also used 2 competitive screws to stabilize 1st ray of the foot to the 2nd ray.At some point post-surgery, the himax staples broke that were used on the 2nd tmt and 3rd tmt fusions.Doctor reports that the patient was non-compliant and was walking on her foot within the 1 month after the operation.He says that the ct scan shows that the 2nd and 3rd tmt joints still experienced fusion even though the patient was non-compliant and the staples broke.

• Brand Name: DYNAFORCE
• Common Device Name: CROSSCLIP
• 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: 15502243
• Report Number: 3020584246-2022-00030
• Device Sequence Number: 7838635
• 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: 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: 11/06/2019
• Device Model Number: 7118-1818KT
• Device Lot Number: 500124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2017
• 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: 76 YR
• Patient Sex: Female