MAUDE Adverse Event Report: NAKANISHI HENRY SCHEIN MASTER; HANDPIECE

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

Doctor was working on a patient to prepare a tooth for a composite filling when drill came apart in the patient's mouth.All parts of the drill were recovered.

• Brand Name: HENRY SCHEIN MASTER
• Type of Device: HANDPIECE
• Manufacturer (Section D): NAKANISHI
• MDR Report Key: 5633701
• MDR Text Key: 44613481
• Report Number: MW5062084
• Device Sequence Number: 1
• Product Code: EFB
• 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: 05/02/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR