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	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Both implants were removed and k-wires were used.The kit and corresponding implant lhr's (listed below) have been reviewed and there is no evidence to suggest the device did not meet specifications prior to distribution.Kit 1443-2501 lot 101251 / implant 100059 lot 101209.Kit 1443-2511 lot 101252 / implant 100060 lot 101210.This failure stems from attempting to press fit the 2.5mm implant into a 2.2mm drilled hole into an unstable proximal phalanx.
Event or Problem Description
During surgery, two of the crosstie implants broke.A 2.2 reamer was used during prep.This event occurred prior to the field update regarding the use of 2.5 reamers.This failure occurred due to the doctor trying to force the 2.5mm implant into the hole drilled by the 2.2mm reamer.During this the proximal phalanx was unstable and the implant broke as result.

• 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: 15501487
• Report Number: 3020584246-2022-00016
• Device Sequence Number: 7831799
• 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 Model Number: 1443-2501
• Device Catalogue Number: 1443-2501
• Device Lot Number: 101251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2016
• 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 Sex: Unknown