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

Catalog Number 659760V

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

In this event it is reported that palodent v3 univ 2 ring refil broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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: failure mode: broken product.Root cause: not determined.Conclusion code: indeterminable.11-21-2023: product not returned, however image in case depicts 1 v3 ring universal blue with one of the tynes broken off.Overmolding date code couldn¿t completely be identified based on the image quality attached, however one code could be identified which was either ¿i¿ for the month of september or ¿l¿ for the month of december (date code for year could not be identified).Traceability from item# 659760v batch# 06963076 which utilized 3 different lots of item# 759870 (v5 ring universal ¿ palodent) which were 06987633, 06987634 & 06987636 does not match to the overmolding month code on the image attached.The 3 batches of item# 759870 were all produced in july of 2023 therefore would have overmolding id date codes of ¿g¿ for july and ¿o¿ for 2023 as defined per (b)(4).The ring complained against in this case does not trace back to item# 659760v batch# 06963076 dhr and retain evaluation will be conducted anyway due to the severity of this case (nwv).Retained: 11-21-2023: final packaging product retains are not kept as per normal procedure.Retains were not pulled for this investigation as the traceability from returned product does not align with manufacturing month/year of the batch provided in case.(nwv) dhr 11-21-2023: dhr for item# 659760v, batch# 06963076 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refil.Work order 06963076 is the packaging work order which utilized 3 different over-molding of the springs to rings production work orders/runs for item# 759870 batches 06987633, 06987634 & 06987636 (v5 ring universal ¿ palodent).The over-molding work order is only to mold the tynes to the spring.Dhr reviews for all molding work orders 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 (b)(4) (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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18118500
• MDR Text Key: 327909782
• Report Number: 2515379-2023-00106
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659760V
• Device Lot Number: 6963076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/09/2023
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1