MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP HALF PIN, ORTHEX 6.0X200XXX BUTTON, HA

Catalog Number UNKNOWN

Device Problem Fracture (1260)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

During orthex explanation (frame removal - large bone) a 40 mm long tip snapped from a 6.0 mm ha pin.It can't be determined whether this occurred prior to frame removal or during.The surgeon had to scrub in, required sterile draping and use "of" instruments to 'core' the snapped tip out.The tip snapped in the proximal anterior tibia of patient's right leg.The case was extended by 40-60 min.

• Brand Name: HALF PIN, ORTHEX 6.0X200XXX BUTTON, HA
• Type of Device: HALF PIN, ORTHEX 6.0X200XXX 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: 18422634
• MDR Text Key: 331680228
• Report Number: 3006460162-2023-00042
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male