MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-PWR-1000 INSERT,PACKED; SCALER, ULTRASONIC

Catalog Number 80799

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

In this event it is reported that a 30k fsi-pwr-1000 insert, packed broke during use and the patient swallowed the broken part.The patient was seen in the hospital, had imaging to determine location of the separated instrument, and it was retrieved in the or of the local hospital.

Manufacturer Narrative

Since this event necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr 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

Dhr: dhr was reviewed and everything meet specification.No deviation found.Insert did not receive.Base on investigation product was in bul.Failure mode - broken tip.Root cause - unexpected failure type.Conclusion code - unexpected failure.

• Brand Name: 30K FSI-PWR-1000 INSERT,PACKED
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18707578
• MDR Text Key: 336196904
• Report Number: 2424472-2024-00361
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D003807991
• UDI-Public: D003807991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• 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: 05/15/2024

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: 80799
• Device Lot Number: 00106163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/12/2024
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1