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

Catalog Number 659760

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that palodent plus univ 2 ring broke during use.Reportedly, no medical intervention was required, no injury.

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.

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
• 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 ; 7178457511
• MDR Report Key: 18216011
• MDR Text Key: 329116992
• Report Number: 2515379-2023-00107
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D0026597601
• UDI-Public: D0026597601
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1