MAUDE Adverse Event Report: W&HDENTALWEK SYNEA; HIGH SPEED HANDPIECE

Model Number WG-99LT

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 01/08/2018

Event Type  Injury  

Event Description

During the course of a routine dental examination, a bur fell out of a wg-99lt into a patients mouth and was swallowed.The headpeice spun outside of the mouth fine, but when it touched the tooth the bur fell out and was swallowed by the patient.The patient had to go to hospital and have the bur removed with endoscopy with no additional issues.The handpiece has been returned for evaluation: the handpiece is clean and in good condition.The chucking mechanism was tested with several chuck tools and no issues were found.Gears and bearings are free of any debris.Lot number indicates chuck mechanism (643), attachment ran for several minutes with noticable temperature change in the head when tested.

• Brand Name: SYNEA
• Type of Device: HIGH SPEED HANDPIECE
• Manufacturer (Section D): W&HDENTALWEK; ignaz-glaser-strada 53; postfach 1 5111; burmoos 51111
• Manufacturer (Section G): W&H DENTALWERK, BURMOOS GMBH; ignaz-glser-strada 53; postfach 1; burmoos 51111
• Manufacturer Contact: bonnie dundas ; 2601 crestview drive; newberg, OR 97132-9257 ; 5035389471
• MDR Report Key: 7240903
• MDR Text Key: 98997760
• Report Number: 3015729-2018-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K993526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: WG-99LT
• Device Catalogue Number: 0.30195000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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
• Patient Age: 30 YR
• Patient Weight: 68