MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP HALF PIN, ORTHEX 6.0X200X25 BUTTON, HA

Model Number HP60-200-25B

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

We used a 4.8 drill and the med student did the drilling and insertion.It was hard to tell if the med student drilled bi-cortically as this may have been the cause of breakage.During insertion of the 6.0x25mm half pin, the ao tip of the half pin broke off in the blue t handle.We cut the half pin with the pin cutter and used the half pin removal tool to try to advance the pin bi-cortical.There was a large amount of torque possibly due to distal tibial callus formation from either patient anatomy or previous fracture/fractures (in general the bone was very thick and difficult to advance half pins).As we struggled to advance, the pin snapped at the thread to shank junction.We had to use a screw removal set to remove the tip of the half pin from bone.

• Brand Name: HALF PIN, ORTHEX 6.0X200X25 BUTTON, HA
• Type of Device: HALF PIN
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 12339134
• MDR Text Key: 280579267
• Report Number: 3006460162-2021-00032
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HP60-200-25B
• Device Lot Number: 9524E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2021
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 113