MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATE TOOL REFILL; INSTRUMENTS, DENTAL HAND

Catalog Number 663100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

In this event it is reported that automate tool broke during use.Outcome is unknown as of this mdr.Further information is pending.

Manufacturer Narrative

There has been a previous report received 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 such.As such, this event 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

Adding udi # : udi # (b)(4).Returned product was 1 flexshaft date code 0622 with coil deformation/weld failure causing the product to not function properly.Capa opened to address weld failures for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of august 2022 (0822).Complaint is considered substantiated.(nwv).

• Brand Name: AUTOMATE TOOL REFILL
• 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: 16371643
• MDR Text Key: 309510763
• Report Number: 2515379-2023-00063
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D0026631001
• UDI-Public: D0026631001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 663100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1