MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. ORTHOPEDIATRIC FEMORAL BLADE PLATE; PLATE, FIXATION, BONE

Model Number 00-1200-3503

Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2018

Event Type  malfunction  

Event Description

Patient came to the operating room to have femoral blade plate and three screws removed.Proximal and distal screws were removed without difficulty.The middle screw per surgeon was cold-welded into the plate.He attempted to remove the screw with two different screw drivers, but damaged the drivers while attempting this.He then used the broken screw removal set but was also unsuccessful.He then used a burr to remove the head of the screw and was then able to remove the plate.He then used a trephine to remove the rest of the screws.The wound was irrigated with saline to remove the metal shavings.Per the surgeon this added 30 minutes to the patient's anesthesia/case time.

• Brand Name: ORTHOPEDIATRIC FEMORAL BLADE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS CORP. ; warsaw IN 46582
• MDR Report Key: 7645664
• MDR Text Key: 112762190
• Report Number: MW5078123
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1200-3503
• Device Catalogue Number: 00-1200-3503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 26