MAUDE Adverse Event Report: AMERICAN EAGLE INSTRUMENTS AMERICAN EAGLE INSTRUMENTS; GRACEY DEEP POCKET CURETTE

Model Number	AEGDP13-14XPX
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received instrument and broken tip.A end tip broke approximately 2.5 mm from end.Visual inspection of instrument indicates this instrument has been well used.Tip has dents, gouges, scratches, etc.Working edge has been worn down to a radius.The coating material has been removed exposing the substrate metal.Instrument has a lot code of 1gp indicating it was manufactured in july of 2011.Manufacturer recommends a life expectancy of 6 months of regular use for these instruments.Working through a distributer this allow approximately 12-18 months from date of manufacturing.This information is provided for each instrument and available on manufacturer website.This instrument is over 6 years past life expectancy.Since 2015, there have been (b)(4) products (aegdp13-14xpx) sold.There have only been 4 product complaints relating to this product.That correlates to a (b)(4) complaints.This is a very small complaint percentage and indicates a user error rather than a manufacturing defect.The tip likely broke due age and excessive force.
Event or Problem Description
Curette tip broke off during root cleaning distolingual corner of tooth 6- (1.Molar right lower jaw).Deep pocket 8 mm.Tip of instrument (~2.5 mm from end) broke off in patients mouth during use.The patient had to undergo surgery to have the tip removed.The tip was successfully removed from the patient and the patient made a full recovery.

• Brand Name: AMERICAN EAGLE INSTRUMENTS
• Common Device Name: GRACEY DEEP POCKET CURETTE
• Manufacturer (Section D): AMERICAN EAGLE INSTRUMENTS; 6575 butler creek rd.; missoula MT 59808
• MDR Report Key: 8753876
• Report Number: 1000127001-2019-00001
• Device Sequence Number: 1342149
• Product Code: EMS
• UDI-Device Identifier: 00841013107771
• UDI-Public: 00841013107771
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2013
• Device Model Number: AEGDP13-14XPX
• Device Catalogue Number: AEGDP13-14XPX
• Device Lot Number: 1GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention