MAUDE Adverse Event Report: LEE MEDICAL BONE SHARK DISPOSABLE BONE MILL

Catalog Number BS101

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  Injury  

Event Description

Bone shark being used to grind bone in 4 level posterior cervical laminectomy and lateral mass lesion (b)(6) 2021.The bone shark was not bone but the side of the device causing plastic to be mixed in with the ground up bone that was to be put back in the patient.The physician was immediately notified.

• Brand Name: BONE SHARK DISPOSABLE BONE MILL
• Type of Device: BONE MILL
• Manufacturer (Section D): LEE MEDICAL ; skillman NJ
• MDR Report Key: 11398607
• MDR Text Key: 234488352
• Report Number: MW5099719
• Device Sequence Number: 1
• Product Code: LYS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2021

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: Health Professional
• Device Expiration Date: 10/01/2002
• Device Catalogue Number: BS101
• Device Lot Number: BS900B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• 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): Required Intervention
• Patient Age: 62 YR