MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 FORCEPS; INSTRUMENTS, DENTAL HAND

Catalog Number	659810V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that palodent v3 forceps broke during use.No injury.
Additional Manufacturer Narrative
Investigation results: 1-31-2024: product returned 1 pair gen 2 forceps batch# a100121 broken at the handle at the customer describes thus substantiating the customers complaint.Note: this is the first complaint for broken forceps for item# (b)(4) batch# a100121.(nwv).1-31-2024: incoming retains are no longer available for review as per 0290-wi-8.2-07 which states retention samples must be maintained for a minimum of six months (received in 01-2022).(nwv).1-31-2024: incoming/receiving documents for item# (b)(4) (gen 2 forceps) batch# a100121 forceps has been pulled, reviewed, and attached to this case.All incoming supplier documentation & certifications meet specifications as well as all visual, dimensional, and functional tests as per 0290-ip-7.5-80-12.A total of (b)(4) forceps was received on 1-20-2022 and aql sampling size for visual inspection was n=29, and functional & dimensional n=68pcs for each test with all inspected forceps meeting all specifications per procedure.(nwv).

• Brand Name: PALODENT V3 FORCEPS
• 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: 18484026
• Report Number: 2515379-2024-00002
• Device Sequence Number: 14164444
• Product Code: DZN
• UDI-Device Identifier: D002659810V1
• UDI-Public: D002659810V1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/05/2024

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: 659810V
• Device Lot Number: A100121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/09/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown