MAUDE Adverse Event Report: DENTSPLY LLC V3 RING UNIVERSAL (GREEN) 2 PACK; INSTRUMENTS, DENTAL HAND

Catalog Number	403342
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 v3 ring universal (green) 2 pack broke during use.No injury.
Additional 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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation: return 9-29-2023: returned product 1 v3 ring universal (green, new and improved design v5) with one of the tynes broken off/missing.Overmolding date codes ¿b¿ for february and ¿n¿ for 2022.Dhr and retain evaluation will be conducted.(nwv) retain 9-29-2023: final packaging product retains are not kept as per normal procedure.Ring over-molding retain from item# (b)(4) batch# 05104833 was pulled, reviewed, and deemed acceptable as per 0290-ip-7.5-60-58 and meet all form/fit/function.(nwv) dhr 9-29-2023: dhr for item# (b)(4) lot# 05122264 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the v3 ring universal (green) 2 pack.Work order (b)(4) is the packaging work order which utilized over-molding of the springs to rings production work order/run item# (b)(4) batch# 05104833.The over-molding work order is only to mold the tynes to the spring.Dhr review for molding item# (b)(4) batch# 05104833 did not indicate any production issues, nor any comments noted, however there is a non-conformance with the documentation as the qc final inspection was not documented as per 0290-ip-7.5-60-58 and left blank.Nc-2023-3023 has been initiated for the dhr documentation non-conformance and the quality department has been notified.(nwv).

• Brand Name: V3 RING UNIVERSAL (GREEN) 2 PACK
• 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: 17737869
• Report Number: 2515379-2023-00100
• Device Sequence Number: 20206936
• Product Code: DZN
• UDI-Device Identifier: D002659900V1
• UDI-Public: D002659900V1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 403342
• Device Lot Number: 05122264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown