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

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
Lhrs have been reviewed and no evidence was found to suggest the implants were non-conforming prior to distribution.The lhr's, manufacturing records, and sterilization records have been reviewed and no evidence was found to suggest the devices did not meet specifications prior to distribution.
Event or Problem Description
Doctor mentioned that he had a case in which some of the hardware experienced mechanical failure.The discovery date of the hardware is unknown.An email was sent to the surgical representative to find out more information regarding the failure.An x-ray was obtained and will be included in the complaint file.The x-ray depicts what appears to be a broken himax implant along with 2 broken screws.The original date of surgery was on (b)(6) 2018.The hardware was not removed or revised and there are no plans to revise the site.Per the sales rep, doctor is satisfied with the outcome of the case and the status of the union.Rep also mentioned that the patient was non-compliant.

• 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: 15606518
• Report Number: 3020584246-2022-00025
• Device Sequence Number: 2277632
• 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: 01/30/2020
• Device Model Number: 7115-1515KT
• Device Lot Number: 500175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2018
• 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: 68 YR
• Patient Sex: Male