MAUDE Adverse Event Report: AMERICAN EAGLE INSTRUMENTS INC. AMERICAN EAGLE P 204SD 3/8"; RESIN HANDLE SCALER

Model Number 204SD

Device Problem Break (1069)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/21/2016

Event Type  malfunction  

Event Description

While scaling the distal-lingual of patient's tooth #1 the tip of an american eagle xp 204s scaler broke 2mm below the gum line and we were unable to locate the tip.We sent the patient to a periodontist and the tip was removed quickly and easily.This scaler was used after the usage of a piezo and curette.Fine scaling was the intended technique with this instrument.Instrument tip lodged subgingivally distal to #1 and had to refer to patient to periodontist to have tip removed.

• Brand Name: AMERICAN EAGLE P 204SD 3/8"
• Type of Device: RESIN HANDLE SCALER
• Manufacturer (Section D): AMERICAN EAGLE INSTRUMENTS INC.
• MDR Report Key: 6147340
• MDR Text Key: 61663571
• Report Number: MW5066533
• Device Sequence Number: 1
• Product Code: ELC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2016

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
• Device Model Number: 204SD
• Device Catalogue Number: AES204SDXPX
• Device Lot Number: 6BD
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1