MAUDE Adverse Event Report: DENTSPLY CAULK AUTOMATRIX SHAFT

Catalog Number 62422603

Device Problem Break (1069)

Patient Problem 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 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 a automatrix shaft broke during use; no injury resulted.

Manufacturer Narrative

Returned product confirmed to be a flexshaft with date code 0621.Returned product observed had a "weld" failure, this is caused when the welding stage of the manufacturing processes is not executed correctly and/or the weld did not hold up after use.The welder is to secure the hex sleeve to the flexible sleeve to create the sub-assembly.If the weld is not secure/successful, the device may become compromised and non-conforming., therefore this complaint is considered substantiated.

• Brand Name: AUTOMATRIX SHAFT
• Type of Device: AUTOMATRIX SHAFT
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave; milford DE 19963
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12704350
• MDR Text Key: 285237760
• Report Number: 2515379-2021-00021
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 62422603
• Device Lot Number: 2005000247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1