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 07/10/2023

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 is reported that automatrix shaft broke during use.No injury occurred.

Manufacturer Narrative

8-2-2023 return investigation: product returned 1 flexshaft date coded 0913 (not from batch 06498993 as input in case) with a broken tip rendering the product unusable.This flexshaft was produced in 09-2013 and exceeds the automate flexshaft useful life rationale which states that automate flexshaft useful life will be established as 24 months, and that if meeting these criteria, complaints will be closed as a repair because the device is beyond its useful life (rationale attached).Dhr for batch# 06498993 will not be reviewed as the returned product confirmed it is not from this batch information.Provided in the case.(nwv).Failure mode: broken product.Root cause: out of lifetime.Conclusion code: expected wear.

• 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
• MDR Report Key: 17327086
• MDR Text Key: 319378913
• Report Number: 2515379-2023-00086
• Device Sequence Number: 1
• Product Code: DZN
• 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: 08/03/2023

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: 06498993
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2023
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1