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

Model Number	1443-2501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Two crosstie implants were broken during insertion (p/n 1443-2501 lot 101930 and p/n 1444-2500 lot 100944).A third implant (p/n 1443-2501 lot 101930) was successfully implanted but then removed after two were broken.This was done due to doctor preference.The implants are supposed to be returned through an ecopak.Rep called and gave details regarding the surgery where he reported the incident is due to user error caused by torqueing the inserter too quickly while trying to get the implant to release from the inserter.All three implants were removed and k-wires were used.
Additional Manufacturer Narrative
Lhrs were reviewed for both the packaged component lots (p/n 1443-2501 lot 101930 and p/n 1444-2500 lot 100944) and the implant lots (p/n 100059 lot 101890 and p/n 100059 lot 100932).No evidence was found to suggest that the implants or the packaged kits did not meet specifications prior to distribution.

• 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: 15501619
• Report Number: 3020584246-2022-00011
• Device Sequence Number: 5286035
• Product Code: HWC
• UDI-Device Identifier: 00815432022045
• UDI-Public: 00815432022045
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 01/12/2021
• Device Model Number: 1443-2501
• Device Catalogue Number: 1443-2501
• Device Lot Number: 101930
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2017
• 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: 64 YR
• Patient Sex: Unknown