MAUDE Adverse Event Report: W AND H DENTAL BURMOOS GMBH SYNEA; HIGH SPEED HANDPIECE

Model Number TA-97 LED +

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2014

Event Type  Injury  

Event Description

A patient swallowed a dental bur and medical treatment was performed to remove it.In the course of dental treatment, the doctor used a w and h synea ta 97 led and high speed handpiece with a gold tapered bur.While adjusting the filling, the bur disassociated from the handpiece and landed over the patient's uvula.The assistant tried to retrieve the bur with suction but was unsuccessful.The doctor tried to use suction and was unsuccessful.The bur fell further down the patient's throat and was no longer visible.The patient then sat up and swallowed the bur.A surgeon was called to assess the situation.The patient was taken to the x-ray department and then referred to (b)(6) medical center in (b)(6).Surgery was performed to remove the bur.The patient was released the next morning in good condition.The patient visited the dental clinic and is doing well.Note #1: the serial number of the device is unknown; the device was returned to rotation without recording the serial number.Investigations show the customer purchased w and h synea ta 97 led and high speed handpiece on two occasions.Ten were purchased (b)(6) 2011 and fifteen were purchased (b)(6) 2014.It is unknown which vintage was used during this event.Note #2: event occurred: (b)(6) 2014.A-dec initially made aware but details unavailable: (b)(6) 2014.A-dec collected last of detailed information: (b)(6) 2014.(b)(4).Reference mfr # 9681479-2015-00001.

• Brand Name: SYNEA
• Type of Device: HIGH SPEED HANDPIECE
• Manufacturer (Section D): W AND H DENTAL BURMOOS GMBH; ignaz-glaser-strasse 53; postfach 1; burmoos 5111 ; AU 5111
• Manufacturer (Section G): A-DEC, INC.; 2601 crestview dr.; newberg OR 97132 925
• Manufacturer Contact: 2601 crestview dr.; newberg, OR 97132-9257
• MDR Report Key: 4606061
• MDR Text Key: 20123416
• Report Number: 3015729-2014-00001
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TA-97 LED +
• Device Catalogue Number: 0.10069734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention