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	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the rep's recollection of the case, the kit in question could have been lot 101252 or 101049.During the review, the work order pick lists were examined for each lot and it was determined that the returned inserter lot 101148 was only used in the packaging of lot 101252.Upon further review of lot 101252, no evidence was found to suggest the device did not meet specifications prior to distribution.As with other broken crosstie implants, the surgeon most likely applied too much shear force on the implant while attempting to implant.The rep confirmed that this is what happened during the first insertion attempt.Another kit was successfully used without any problems.
Event or Problem Description
Broken crosstie implant was found during ecopak receiving on 02/20/2017.Rep was called for questions.Rep gave facility and doctor name and mentioned that he thinks the case happened in (b)(6) of 2016.This info was used to find the invoice for the case.This invoice is the only case with this doctor in which multiple crosstie kits were 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: 15501603
• Report Number: 3020584246-2022-00009
• Device Sequence Number: 17502529
• 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 Expiration Date: 04/01/2021
• Device Model Number: 1443-2511
• Device Catalogue Number: 1443-2511
• Device Lot Number: 101252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 47 YR
• Patient Sex: Female