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 09/28/2023

Event Type  malfunction  

Event Description

In this event it is reported that a automatrix shaft tip broke during use.Reportedly, no injury occurred.

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

Investigation: product not returned.Image attached shows flexshaft date code not visible with weld failure/coil deformation.Capa opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by sarasota.Since december 2020 (date code 1220) through implementation date of august 2022 (0822).Based off the batch information provided "721", which would translate to 0721 or 07-2021.Therefore, complaint is considered substantiated.No dhr or retain evaluation can be conducted, as the batch information provided is presumed to the be "date code".Which, would consist of all batches manufactured in 07-2021 in sarasota.Therefore, this information is not obtainable (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: 17852621
• MDR Text Key: 324707214
• Report Number: 2515379-2023-00102
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/11/2023

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 Catalogue Number: 62422603
• Device Lot Number: 721
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/02/2023
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1