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	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The kit lhr (p/n (b)(4), lot 101930) was reviewed and the implant lot (p/n (b)(4), lot 101890) was confirmed by the work order pick list within the kit lhr.The implant lhr was also reviewed and no evidence was found in either file that suggests the device did not meet specifications prior to distribution.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.
Event or Problem Description
A 2.5 mm crosstie implant broke while being inserted with a universal inserter.A 2.2 reamer was used because the rep was not notified of the original field update that was issued as an action plan.Per the rep, he did not notice any torque being applied on the implant prior to the failure.The failure occurred while attempting to insert the implant into the distal end of the proximal phalanx.The implant was removed and another crosstie kit was opened and successfully used.

• 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: 15501661
• Report Number: 3020584246-2022-00019
• Device Sequence Number: 20147669
• 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: 12/01/2021
• Device Model Number: 1443-2501
• Device Catalogue Number: 1443-2501
• Device Lot Number: 101930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Female