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

Model Number TA-98LW

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

S/n: (b)(4) was evaluated on 1/30/2018, there was no record of previous repair history at a-dec.The handpiece arrived with the cap on finger tight, the spring washer was included in the package but was not inside the head where it belongs.The loose cap is the older style that requires loctite during the assembly process.No loctite was used and the turbine was a generic style leading the evaluator to believe that this handpiece had been repaired elsewhere.The complaint was that the cap came off while in use on the patient, our conclusion is the device was repair previously by a non-authorized service center that used generic parts and did not have the appropriate instructions to use loctite on the cap to keep it in place.

Event Description

During the course of a routine dental examination, a cartridge from a synea high speed handpiece (ta-98lw) came out and the turbine fell into the patient's mouth.The doctor and assistant were able to catch the turbine before the patient swallowed it.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: 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: 7243910
• MDR Text Key: 99327449
• Report Number: 3015729-2018-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 7 YR
• Event Location: Other
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2004
• 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): Other
• Patient Age: 30 YR
• Patient Weight: 68