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)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that palodent plus univ 2 ring broke during use.Reportedly, no medical intervention was required, no injury.
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr 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.
Additional Manufacturer Narrative
Investigation results: (b)(6) 2024: returned product 1 v3 ring universal (light blue, new and improved design v5) with 2 of the tynes broken off as described in the detail of this case.Overmolding date codes ¿c¿ for (b)(6) and ¿o¿ for 2023.Dhr nor retain evaluation can be conducted as there is no relevant batch information provided in this case.(nwv) 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18216011
• Report Number: 2515379-2023-00107
• Device Sequence Number: 6748064
• Product Code: DZN
• UDI-Device Identifier: D0026597601
• UDI-Public: D0026597601
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 659760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown