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	01/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Broken crosstie implant was found during ecopak receiving on 03/13/2017.Email correspondence to the rep concerning this will be included in this file.The rep provided the surgeon name and date.The rep claimed, "the doctor twisted the inserter too hard while pushing or just had it at the right angle so it snapped." other kits were used on other toes, including one from the same lot number, and there were no additional issues.The doctor opted to leave proximal end of the implant in the patient and a k-wire was placed next to it for stability.
Additional Manufacturer Narrative
The lhr for both the kit (p/n 1443-2511, lot 101471) and the implant(p/n 100060, lot 101442) were reviewed and no evidence was found to suggest that the devices did not meet specification prior to distribution.All the dimensions were found to be within specifications.

• 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: 15501616
• Report Number: 3020584246-2022-00010
• Device Sequence Number: 5439088
• 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: 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: 1443-2511
• Device Catalogue Number: 1443-2511
• Device Lot Number: 101471
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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: 69 YR
• Patient Sex: Male