MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX INTRO PKG-DUAL; INSTRUMENTS, DENTAL HAND

Catalog Number 663032

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.

Event Description

In this event it is reported that automatrix broke during use.The tightening assembly shaft broke when tightening automatrix band inside patients mouth.Outcome of this event is unknown as of this mdr.

Manufacturer Narrative

A capa was 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).Batch: 04759251 utilized flex shaft assembly item: 20780, batch: 04759292 which was produced in oct 2021 (date code: 1021).Complaint is considered substantiated.(nwv).

• Brand Name: AUTOMATRIX INTRO PKG-DUAL
• 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: 15581184
• MDR Text Key: 307010852
• Report Number: 2515379-2022-00055
• Device Sequence Number: 1
• Product Code: DZN
• 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: 11/11/2022

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: 663032
• Device Lot Number: 04759251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/10/2022
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1