MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSTIE; 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	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following lhr's were reviewed and no evidence was found to suggest the devices did not meet specifications.Part number lot number 1443-2501 102861 100059 102827 the failure mode was not recreated in a cadaver lab with a first-time user.However, with intention and difficulty, the failure mode was successfully recreated.The previous investigations suggest that the failure occurs when a slip occurs due to the instable proximal phalanx and a resulting torque is placed on the implant.This torque is significant enough to break the implant if the insertion force is being applied to the distal end of the inserter.The force required to fully insert the implant is reduced when a 2.5 mm reamer is used.After use with a 2.5mm reamer, the implant was still securely held in place by a tight fit during the cadaver lab.No complaints have been opened regarding crosstie implants that did not perform as intended after implementation when a 2.5mm reamer was used.However, a 2.2mm reamer may still be used, especially in the cases of poor/soft bone quality.
Event or Problem Description
A crosstie implant fractured during insertion.The implant was being inserted with a universal inserter and the hole was reamed with a 2.2 reamer.The patient had slightly poor/soft bone quality.There was no harm to the patient.The implant was removed and another 2.5mm implant was successfully inserted.The incident resulted in an estimated 5-minute delay in surgery and doctor was pleased with the outcome and did not have any negative comments regarding the broken implant.The implant was removed and another implant was successfully inserted.

• Brand Name: CROSSTIE
• 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: 15502064
• Report Number: 3020584246-2022-00023
• Device Sequence Number: 12724841
• Product Code: HWC
• UDI-Device Identifier: 00815432022045
• UDI-Public: 00815432022045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 12/01/2022
• Device Model Number: 1443-2501
• Device Catalogue Number: 1443-2501
• Device Lot Number: 102861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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 Sex: Unknown