MAUDE Adverse Event Report: DENTSPLY LLC PALODENT PLUS PIN TWEEZERS; INSTRUMENTS, DENTAL HAND

Catalog Number 659820

Device Problem Break (1069)

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

Event Type  malfunction  

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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that palodent plus pin tweezers - the prong broke off of the new palodent tweezers.No injury occurred.

Manufacturer Narrative

Investigation return 5-9-2024: returned product 1 pair of palodent plus pin tweezers item# 759820 batch# 100322 was inspected and confirmed to be missing the ¿pin¿ at the tips of the tweezers which aids in holding the tab matrices in place within the instrument.The returned product is not to specification and dhr review will be conducted.(nwv) retain 5-9-2024: incoming retain for item# 759820 batch# 100322 is not available for review as per (b)(4) which states retention samples must be maintained for a minimum of six months (received 10-4-2022).(nwv dhr 5-9-2024: receiving inspection for item# 759820 batch# 100322 has been attached to this case.All incoming supplier documentation/certifications meet specifications as well as all visual, dimensional, and functional tests as per 0290-ip-7.5-80-15.A total of (b)(4) pin tweezers was received on 10-4-2022 and aql sampling size for visual was (b)(4) pcs and functional each test was (b)(4) pcs, with all individual pin tweezers meeting all specifications per procedure.Review of the inspection resulted in no issues and all inspections were performed on the lot and deemed acceptable by quality.(nwv).

• Brand Name: PALODENT PLUS PIN TWEEZERS
• 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: 19091694
• MDR Text Key: 340122241
• Report Number: 2515379-2024-00018
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D0026598201
• UDI-Public: D0026598201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 659820
• Device Lot Number: ZZ600L (DON'T THINK THIS IS RI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2024
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1