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

Model Number TA-97LW

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

S/n (b)(4) was evaluated on 1/31/2018, the device was purchased on (b)(6) 2013, there are no records of previous repairs conducted at a-dec.The technician was unable to duplicate the complaint of "bur falls out while in the mouth." the technician tested the handpiece with a test bur, and the bur held in the chuck for the duration of the testing process.During the test, pressure was applied and released in efforts to duplicate the complaint, with no success.It appears as though the handpiece was not properly maintained as the turbine is badly worn, there are no signs of lubrication and it is dark in color.The chuck is so weak the chuck tester slips out before reaching the 1st line.The technician was also able to remove the test mandrel without pressing on the release button.

Event Description

Dentist returned a synea ta-97lw high speed handpiece for repair with a complaint stating; "bur falls out while in the mouth, seems to be locked otherwise" 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&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: 7246521
• MDR Text Key: 99219721
• Report Number: 3015729-2018-00004
• 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: 02/07/2018,02/06/2018

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: TA-97LW
• Device Catalogue Number: 0.10069732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2018
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• 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