MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSCLIP; STAPLE, FIXATION, BONE

Model Number	7118-1818KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rep reports that doctor performed a 2nd and 3rd tmt fusion case with 4 clips.Upon follow-up post-procedure, the most medial clip on the 2nd tmt fusion appeared broken on x-ray which was one of the three 18mm x 18mm himax implants used in the case.Rep reports that the patient is doing fine and the joint has experienced proper fusion.No revision surgery is planned to date.No resolution.Patient is reported to be doing okay and joint is properly fused.
Additional Manufacturer Narrative
The following lhr's have been reviewed and no evidence has been found to suggest the implants did not meet specifications prior to distribution.Description, part number, lot number: dynaforce himax kit 18mm x 18mm 7118-1818kt 300055; dynaforce himax implant 18mm x 18mm electropolished 240008ep 103068; dynaforce himax implant 18mm x 18mm electropolished 240008ep 102887r; dynaforce himax implant 18mm x 18mm electropolished 240008ep 103043.

• Brand Name: CROSSCLIP
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 15501585
• Report Number: 3020584246-2022-00026
• Device Sequence Number: 20193293
• 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: 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: 09/26/2020
• Device Model Number: 7118-1818KT
• Device Lot Number: 300055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• 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: Male