MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP HALF PIN, SB, ORTHEX 4.0X150X10 BUTTON, HA

Catalog Number HPP40-150-10B

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Patient had bilateral orthex small bone tibial frames placed on (b)(6) 2023.A few months after in clinic was noted that threaded portion of halfpin was broken from shaft, surgeon removed shaft of half pin in clinic.Patient returned to or to have broken portion removed from bone.Mechanism of what caused the halfpin to break is unknown.

• Brand Name: HALF PIN, SB, ORTHEX 4.0X150X10 BUTTON, HA
• Type of Device: HALF PIN, SB, ORTHEX 4.0X150X10 BUTTON, HA
• 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: 18455932
• MDR Text Key: 332206773
• Report Number: 3006460162-2024-00002
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NANA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: HPP40-150-10B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization