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

Catalog Number 659810V

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 palodent v3 forceps broke during use in patient's mouth.No injury occurred.

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.

Manufacturer Narrative

1-5-2023: returned product 1 pair of forceps with lot a070121 etched on the handle.The returned forceps broke in half at the ¿pin¿ component of the forceps as the customer describes.The complaint is considered substantiated.(nwv).Dhr: 1-5-2023: incoming/receiving documents for lot# a070121 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-ri-instruments.A total of (b)(4) forceps was received on 7-21-2021 and aql sampling size for visual inspection was n=68, and functional/dimensional n=68pcs and n=5 hardness testing, with all inspected forceps meeting all specifications per procedure.(nwv).Retained: 1-5-2023: incoming retains are kept from the initial batch of 68 samples tested and therefore meet specifications as per 0290-ip-ri-instruments.(nwv).Root cause: not determined.Conclusion: indeterminable.

• Brand Name: PALODENT V3 FORCEPS
• 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: 15880669
• MDR Text Key: 305784602
• Report Number: 2515379-2022-00058
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659810V
• Device Lot Number: A070121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2022
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1