MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC MULTI-AXIAL CORRECTION SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 13080

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2017

Event Type  malfunction  

Event Description

When removing mako pins from the leg, one of the pins broke off.The pin was noted to be in remaining in the patient.Per doctor, he did not remove the broken piece of pin from the patient.

• Brand Name: MULTI-AXIAL CORRECTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS, LLC; 6303 blue lagoon drive; suite 100; miami FL 33126
• MDR Report Key: 6724603
• MDR Text Key: 80762555
• Report Number: 6724603
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/24/2017

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: 13080
• Device Catalogue Number: 13080
• Device Lot Number: W44720
• Other Device ID Number: 13080
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2017
• Event Location: Other
• Date Report to Manufacturer: 05/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR