MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND

Catalog Number 659760V

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 a palodent v3 univ 2 ring refil broke during use.No injury occurred.

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 21cfr 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.

Manufacturer Narrative

Investigation results: return: 5-2-2024: product not returned; image in case depicts 1 palodent v3 narrow/dark blue ring (new and improved design v5) with a broken tyne.Over-molding date codes confirmed ¿b¿ for february and ¿n¿ for 2022.Product does not meet specifications, dhr and retain evaluation will be conducted.(nwv).Retain: 5-2-2024: final packaging product retains are not kept as per normal procedure.Ring over-molding retain from item#: 759880, batch#: 05173195 was pulled, reviewed, and deemed acceptable as per 0290-ip-7.5-60-58 and meet all form/fit/function.(nwv).Dhr: 5-2-2024: dhr for item#: 659700v, batch#: 05270343 has been pulled and reviewed.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 starter kit.Work order: (b)(4) is the packaging work order which utilized over-molding of the springs to rings production work order/run item#: 759880, batch#: 05173195 (v5 ring universal ¿ palodent; mfg 02-2022).The over-molding work orders is only to mold the tynes to the spring.Dhr review did not indicate any production issues, nor any comments noted with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-ip-7.5-60-58.(nwv).

• Brand Name: PALODENT V3 UNIV 2 RING REFIL
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19200888
• MDR Text Key: 341367286
• Report Number: 2515379-2024-00022
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/05/2024

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: 659760V
• Device Lot Number: 05270343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2024
• Initial Date Manufacturer Received: 04/26/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1