MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 90 DEG LOCKING CANNULATED CHILD BLADE 50MM X 10MM X 3 HOLE

Model Number 00-1200-3511

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

2.0 guide wire kept deflecting when placing into bone.Wires were very flexible/bendy.Resulted in a delayed case of 2 hours, inaccurate xrays and inappropriately place wires.Due to this, a plate had to be put in freehand causing a plate to be bent.

• Brand Name: 90 DEG LOCKING CANNULATED CHILD BLADE 50MM X 10MM X 3 HOLE
• Type of Device: LOCKING CANNULATED CHILD BLADE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 15559279
• MDR Text Key: 306266174
• Report Number: 3006460162-2022-00028
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1200-3511
• Device Catalogue Number: 00-1200-3511
• Device Lot Number: 223918-B
• Patient Sequence Number: 1
• Patient Sex: Male