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

Catalog Number 62422603

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

In this event it is reported that a automatrix shaft broke during use.No injury occurred.

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Returned product was 1 flexshaft date code 0522 with coil deformation/weld failure resulting in the burr/tip component to break off 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 (b)(6) 2022 (0822).Complaint is considered substantiated.Dhr for batch 06611011 attached, note that the batch complained against was kitted in jan 2023 and does not trace back to the returned product manufacturing date code (product complained against is not from batch 06611011) and the actual batch of the returned product is unknown.(nwv).

• Brand Name: AUTOMATRIX SHAFT
• 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: 17459585
• MDR Text Key: 320422589
• Report Number: 2515379-2023-00089
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 62422603
• Device Lot Number: 06611011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2023
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1