MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 1.25MM X 150MM SS GUIDE WIRE, THREADED

Catalog Number	01-9473-3115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) described to me that during a tri-plane distal tibial fracture he was attempting to place guide wires for 4.0 mm screws.After placing his initial guidewires into the distal tibia, and attaining adequate reduction, dr.Cardin says he tried to replace or redirect, one of his guidewires, and subsequently the guidewire broke as soon as he tried to redirect it with the wire driver.He also states that multiple other wires had bent significantly during this procedure, four to be exact.He attempted to switch wire drivers to a different system to see if that would help, and subsequently broke two more pins, leaving a portion of one of the threaded tips of the pins inside the patient's distal, tibia, and making it difficult to retrieve the part that had broken off.Even in an attempt trying to retrieve one of the pins that had snapped off with a pair of pliers, the tips would continue to break.One wire broke into about seven pieces.

• Brand Name: 1.25MM X 150MM SS GUIDE WIRE, THREADED
• Common Device Name: 1.25MM X 150MM SS GUIDE WIRE, THREADED
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 20467639
• Report Number: 3006460162-2024-00059
• Device Sequence Number: 7612459
• Product Code: KIJ
• UDI-Device Identifier: 00840194465359
• UDI-Public: 00840194465359
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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?: Yes
• Device Catalogue Number: 01-9473-3115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 54 KG