MAUDE Adverse Event Report: COLTENE WHALEDENT INC. UNITY; DRILL

Model Number ST3

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

The patient was having fillings when the dentist used a unity drill and the head of the drill snapped off in the patients mouth.The dentist managed to retrieve this and the patient was not harmed at all.

Manufacturer Narrative

Customer states they received (1) unity drill refill pack (st3), lot h85657, and the head of the drill snapped off in the patient's mouth.The patient was not harmed.The customer did not return any product for analysis.Complaint analysis: one additional complaint exists for the drill separating from the shank.Because the product was not returned we cannot determine whether or not the drill broke or separated from the shank.If the drill separated from the shank, the drill could have been associated with the batch of drills involved in the recall (please see the attached document).If the drill broke, there are a few possibilities as to why this could happen.Per the risk file for intraoral drills (90693-022), breaking could have been caused by: the customer failing to observe that the drill is dull; in turn, applies additional force to the drill.Skipping or incorrectly performing passivation resulting in the drill being susceptible to corrosion and fracture.The customer receiving a drill that is oversized or undersized.Additional possible root cause: customer applied excessive lateral force to the drill during the drilling process.Root cause analysis: why? customer states product received snapped off in the patient?s mouth.Why? customer is dissatisfied with the material strength of the drill.Why? customer expectations do not meet final delivered product quality.Why? see possibilities listed above.

• Brand Name: UNITY
• Type of Device: DRILL
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7800510
• MDR Text Key: 117999245
• Report Number: 2416455-2018-00005
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR