MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSTIE INTRAOSSEOUS FIXATION SYSTEM; SCREW, FIXATION, BONE

Model Number	1443-2511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Crossroads received a broke crosstie implant that was still lodged in the inserter on (b)(6) 2016.Contact was made with event reporter and it was discovered that the implant broke during insertion.Another crosstie kit was opened and successfully used.Broken fragments of implant were removed.The lhr was reviewed for p/n 1443-2511 lot 101471.The implant lhr was also reviewed (p/n 100060 lot 101442).No evidence was found to suggest the device or the implant did not meet specification prior to distribution.
Event or Problem Description
Crossroads received a broke crosstie implant that was still lodged in the inserter on (b)(6) 2016.Contact was made with event reporter and it was discovered that the implant broke during insertion.Another kit was opened and successfully used.Broken fragments of implant were removed.

• Brand Name: CROSSTIE INTRAOSSEOUS FIXATION SYSTEM
• Common Device Name: SCREW, 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: 15501423
• Report Number: 3020584246-2022-00007
• Device Sequence Number: 15392345
• Product Code: HWC
• UDI-Device Identifier: 00815432022052
• UDI-Public: 00815432022052
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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 Model Number: 1443-2511
• Device Catalogue Number: 1443-2511
• Device Lot Number: 101471
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2016
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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: 14 YR
• Patient Sex: Female