MAUDE Adverse Event Report: PALISADES DENTAL, LLC IMPACT AIR 45; HANDPIECE

Model Number 407

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Palisades dental was notified on (b)(6) 2019 that a clinical incident occured sometime in (b)(6) 2018 as "the handpiece was used to section a tooth in the upper quadrant.The bur rotated within the chuck of the handpiece and dislodged.The patient had a rubber dam barrier in place, isolating the tooth and quadrant.The bur was retrieved without incident".Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Palisades dental performed an investigation and concluded that the failure is not manufacture related, rather related to the failure of following instructions for use.

Event Description

Palisades dental was notified on (b)(6) 2019 that a clinical incident occured sometime during (b)(6) 2018 as "the handpiece was used to section a tooth in the upper quadrant.The bur rotated within the chuck of the handpiece and dislodged.The patient had a rubber dam barrier in place, isolating the tooth and quadrant.The bur was retrieved without incident".The reported complaint did not result in an injury or need for intervention.The dentist could not provide the specific date of the incident or any details regarding the patient.

• Brand Name: IMPACT AIR 45
• Type of Device: HANDPIECE
• Manufacturer (Section D): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer (Section G): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer Contact: maureen mcgovern ; 111 cedar lane; englewood, NJ 07631 ; 2015690050
• MDR Report Key: 8370179
• MDR Text Key: 139825392
• Report Number: 3003963943-2019-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407
• Device Lot Number: 7541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1