MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSCLIP IMPLANT SYSTEM; Staple, fixation, bone

Model Number	7120-2020KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following lhr's were reviewed and no evidence was found to suggest the device did not meet specifications prior to distribution.Kit; 7120-2020kt, 102442, finished clip; 240011ep, 102436, pre ep clip; 240011, 102410.Conversations with doctor indicate that the allograft has fused with the bone.At this time, he does not have any plans to perform an additional surgery in order to revise or explant the hardware.He will continue to monitor the patient's progress for more stable fusion at the bone and allograft interface.If any updates or received or a revision surgery is performed, this complaint file will be updated.
Event or Problem Description
Doctor implanted a 20 mm dynaforce clip across an allograft wedge in order to promote fusion.During a routine follow up visit, doctor discovered that the implant had fractured in both legs.He also stated the allograft seemed to be experiencing fusion.However, he was not confident in the extent of the fusion.He plans to monitor the patient and see if the joint continues to exhibit fusion.Doctor does not currently have any plans to revise or explant the hardware.

• Brand Name: CROSSCLIP IMPLANT SYSTEM
• 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: 15501491
• Report Number: 3020584246-2022-00022
• Device Sequence Number: 20791434
• Product Code: JDR
• UDI-Device Identifier: 00815432023394
• UDI-Public: 00815432023394
• 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: 07/18/2019
• Device Model Number: 7120-2020KT
• Device Lot Number: 102442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2017
• 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 Sex: Unknown