MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH SYNEA; HIGH SPEED HANDPIECE

Model Number TK-98L

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

Patient Problem No Code Available (3191)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

The dentist stated the handpiece malfunctioned but did not return the handpiece for evaluation.Note# 1 event occurred: (b)(6) 2016.A-dec initially made aware but all details were unavailable: (b)(6) 2016.A-dec collected last of the detailed information: (b)(6) 2016 device not returned to manufacturer.

Event Description

In the course of a routine dental treatment the doctor used a w&h synea ta-98l led high speed handpiece, the bur came loose from the handpiece and the patient swallowed the dental bur.An x-ray was taken, the patient passed the bur without medical intervention or patient injury.

• Brand Name: SYNEA
• Type of Device: HIGH SPEED HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser-strasse 53; bürmoos, austria 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser-strasse 53; bürmoos, austria 5111 ; AU 5111
• Manufacturer Contact: bonnie dundas ; 2601 crestview drive; newberg, OR 97132 ; 5035389471
• MDR Report Key: 5458548
• MDR Text Key: 39354561
• Report Number: 3015729-2016-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/18/2016

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: Dentist
• Device Model Number: TK-98L
• Device Catalogue Number: 0.30019001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention