MAUDE Adverse Event Report: W&H DENTALWERK, BURMOOS GMBH SYNEA; AIR DRIVEN HANDPIECES

Model Number TA-98LW

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

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 malfuction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude permentant injury.

• Brand Name: SYNEA
• Type of Device: AIR DRIVEN HANDPIECES
• Manufacturer (Section D): W&H DENTALWERK, BURMOOS GMBH; ignaz-glaser-strada 53; postfach 1 5111; burmoos, ; AU
• Manufacturer (Section G): W&H DENTALWERK, BURMOOS GMBH; ignaz-glser-strada 53; postfach 1 5111; burmoos, ; AU
• Manufacturer Contact: bonnie dundas ; 2601 crestview drive; newberg, OR 97132-9257 ; 5035389471
• MDR Report Key: 7296569
• MDR Text Key: 101161077
• Report Number: 3015729-2018-00005
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: TA-98LW
• Device Catalogue Number: 0.10039832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2018
• Device Age: 15 YR
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 68