MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX EXTRA SHAFT ASSY; INSTRUMENTS, DENTAL HAND

Model Number 663016

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

In this event it is reported that automatrix extra shaft assy broke during use.The outcome of this event is unknown as of this mdr.

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

6-19-2023: returned product was only the tip of the flexshaft assembly which is composed of the burr component and the collet subassembly.The tip of the flexshaft inside the collet subassembly where the coil spring is welded together has evidence of weld failure which resulted in the spring coil breaking loose and the tip becoming detached.Date code could not be verified as this is located on the bushing at the base of the flexshaft assembly and therefore without batch information provided in case nor date code of month-year manufactured can be identified.Root cause/conclusion code are inconclusive based on information provided/returned product condition and also can not be confirmed if the flexshaft was manufactured and if it is pre or post implementation of capa-2021-375.It is also indeterminable if the flexshaft assembly meets criteria for useful life rationale of 2 years from date of manufacture (rationale attached).Dhr nor retain evaluation will be conducted as described no batch information provided in case.(nwv).

• Brand Name: AUTOMATRIX EXTRA SHAFT ASSY
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16875979
• MDR Text Key: 314634816
• Report Number: 2515379-2023-00075
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D0026630161
• UDI-Public: D0026630161
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 663016
• Device Catalogue Number: 663016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/16/2023
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1