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

Catalog Number 663100

Device Problems Break (1069); Unraveled Material (1664)

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

Event Type  malfunction  

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

Event Description

In this event it was reported that automate tool broke.This occurred during a simple filling that was being performed when the wrench broke.The coil unraveled during patient use and the tip broke off.The instrument was sterilized in an autoclave then sent back.No one was harmed and no medical attention was required.

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

Event Description

In this event it was reported that automate tool broke.This occurred during a simple filling that was being performed when the wrench broke.The coil unraveled during patient use and the tip broke off.The instrument was sterilized in an autoclave then sent back.No one was harmed and no medical attention was required.

Manufacturer Narrative

A capa has been opened to address weld failures, coil / spring tears / deformation and "broken tip" for product manufactured by sarasota since (b)(6) 2020.Complaint is considered substantiated.

• 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: 13283174
• MDR Text Key: 286243345
• Report Number: 2515379-2022-00031
• Device Sequence Number: 1
• Product Code: DZN
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 663100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/04/2022
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1