MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH SYNEA; AIR DRIVEN HANDPIECE

Model Number TA-98 LW

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

We, w&h as the manufacturer, were not able to evaluate the device as it was not returned to us.

Event Description

During a routine dental procedure the handpiece head fell apart and pieces fell into the patient's mouth, to the dr's knowledge all of the parts were suctioned out of the patient's mouth.There were no injuries in this instance, however there have been previous reports where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude permanent injury.

• Brand Name: SYNEA
• Type of Device: AIR DRIVEN HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: anja lindner ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 7344383
• MDR Text Key: 103159770
• Report Number: 9681479-2018-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K070663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: TA-98 LW
• Device Catalogue Number: 0.10039832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 68