MAUDE Adverse Event Report: DENTSPLY LLC PALODENT 360 6.5MM RF; INSTRUMENTS, DENTAL HAND

Catalog Number	659603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that palodent 360 6.5mm rf broke during use.
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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Additional Manufacturer Narrative
Dhr 10-24-2024: dhr for item# 659603 lot# 05562112 has been pulled, reviewed, and attached to this case.Dhr did not identify any issues during the execution of the packaging work order of the palodent 360 6.5mm refill, with all inspections performed and deemed acceptable by the operators and quality as per (b)(4).Work order# (b)(4) is the packaging production order which utilized item# 760032 lot# 05803334 manufacturing work order/lot for the 6.5mm circumferential matrix system.Dhr for item# 760032 lot# 05803334 has also been pulled, reviewed, and attached to this case.Dhr review did not identify any issues during production either by the operator(s) nor quality, with all inspections & testing performed as per (b)(4).During aql sampling by the operators performed every hour during production (for visual and functional criteria), if defects are detected the operators are to record the failure/mode on the pvs and perform a 100% inspection on the lot and the lot from the previous hours until no failures are observed.The operators conducted multiple 100% inspections due to dents in the band and heat steak failures (visual test only).Quality is then to perform a final inspection at aql 0.65 per assembly machine (max 8) to the inspection points listed in the ip, which includes visual inspection criteria and functional testing at and aql of 4.0 as per (b)(4) (thumbwheel detent torque) & (b)(4) (heat stake retention test).Quality final inspection yielded passing results for each lot of product produced by each machine submitted by the operators.The testing results meet the specifications per (b)(4) torque test requirements passing/acceptable testing between minimum 0.22 cnm and maximum 1.68 cnm.The returned product will be evaluated, inspected, and tested per (b)(4).Retain 10-24-2024: final packaging product is not retained as per normal procedure.Retains from item# 760032 lot# 05803334 were not available for review as per (b)(4) which states retention samples must be maintained for a minimum of six months (produced 08-2022).(b)(6).

• Brand Name: PALODENT 360 6.5MM RF
• 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: 20412787
• Report Number: 2515379-2024-00049
• Device Sequence Number: 18240076
• Product Code: DZN
• UDI-Device Identifier: D0026596031
• UDI-Public: D0026596031
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/04/2025

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: 659603
• Device Lot Number: 05562112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/08/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown