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

Model Number 401

Device Problems Device Maintenance Issue (1379); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

As part of palisades dental's investigation, on 01-jun-2018 a review of palisades dental sales records confirmed the sale of (b)(4) on 25-mar-2016 to (b)(4).In (b)(4).Records further indicate that the handpiece has not been at palisades dental for service since it was originally sold.A review of manufacturing records for (b)(4) did not find any abnormalities with the batch record or associated records.On 05-jun-2018 handpiece (b)(4) was received and evaluated.The following was found: cap and turbine are non-palisades dental parts.Palisades dental has determined that the failure of handpiece (b)(4) is not manufacturer related, rather it is related to service that did not comply to manufacturer's recommendations, and/or the use of non-palisades dental parts - any or all of these factors contributed to the alleged failure.Palisades dental has determined that either use of non-palisades dental parts and/or service that did not potentially contributed to the event.Palisades dental deems no action needed since the ifu instructs the user on returning the device to palisades dental for evaluation and service.

Event Description

It was reported that during an apicoetomy #3 a dentsply multi purpose surgical bur (mubur) came out of handpiece (b)(4) while doctor was using and the bur went into the sinus of a female patient.The bur was later removed by an oral surgeon and the patient is doing fine.

• 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: 7610695
• MDR Text Key: 111382973
• Report Number: 3003963943-2018-00003
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 401
• Device Lot Number: 7289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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
• Patient Outcome(s): Required Intervention