MAUDE Adverse Event Report: DENTSPLY LLC PALODENT PLUS UNIV 2 RING REF; INSTRUMENTS, DENTAL HAND

Catalog Number	659760
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that palodent plus univ 2 ring ref broke during use.No injury occurred.
Additional 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 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.
Additional Manufacturer Narrative
Investigation return.Ring is broken - fail.Unable to investigate - dhr - because the lot number is unknown.Failure mode - broken product.Root cause - not determined.Conclusion code - indeterminable.

• Brand Name: PALODENT PLUS UNIV 2 RING REF
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20659925
• Report Number: 2515379-2024-00053
• Device Sequence Number: 15513195
• Product Code: DZN
• UDI-Device Identifier: D0026597601
• UDI-Public: D0026597601
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 659760
• Device Lot Number: NONE
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown