MAUDE Adverse Event Report: KLS-MARTIN L.P. LEVEL ONE; BIT, DRILL

Model Number 25-469-11-07

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

A drill bit was being used in the patient's mouth and as they were drilling the drill bit went through the other side of the mouth and the drill bit was bent.In order to get it out they had to cut the end of the drill bit off that was bent and backed out the rest of the drill bit.No foreign object was retained and the drill bit was removed from the field.

• Brand Name: LEVEL ONE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): KLS-MARTIN L.P.; 11201 saint john¿s industrial pkwy s; jacksonville FL 32246
• MDR Report Key: 12432183
• MDR Text Key: 270167913
• Report Number: 12432183
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-469-11-07
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Weight: 59