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

Model Number 401

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/31/2018

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 (b)(6) 2018 to (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 at palisades dental along with a representative sample bur used during the procedure, ultrasharp diamond bur (087-9890).The handpiece was examined by palisades dental technician the following was found: chuck does not grip the sample bur ultrasharp diamond bur (087-9890).Sample bur can be removed when tugged by the user.It is apparent visually that the bur is gold in color.Palisades dental technician contacted a (b)(4) representative to ask for information on the material of the bur.Palisades dental technician was informed by a (b)(4) representative that the shank of the ultrasharp diamond bur (087-9890) is stainless steel with gold plating.Palisades dental notes the obvious visual difference of the gold plating on the shank of the bur and cannot conclusively determine what if any impact the material/coating difference may have on the chuck grip.The evaluation included testing the handpiece with three other sample burs provided by capital endodontics.In all three cases the chuck did hold well the alternate burs provided by capital endodontics (all of these were stainless steel shanks with carbide tips and silver in color): (b)(4) surgical bur carbide friction grip # 2 (part # 0840538), (b)(4) surgical bur carbide friction grip # 4 (pat # 084-0546) & brasseler friction grip lindemann bone cutter carbide (part # h161.31.016).Palisades dental determined that the root cause was not manufacturer related, rather it was related to use of a bur that does not fully and securely engage in the chuck and failure to follow instructions for use.Palisades dental deems no action needed since instructions for use are adequate.Section # 6 burs: always tug on the bur, after the chuck is loaded, to confirm that the bur is securely in place.Section # 7 operation: test the bur for security by tugging the bur with your fingers.

Event Description

It was reported that during an apicoectomy #15 a bur came out of handpiece (b)(4) while doctor was using it and the bur is now in the patient's sinus cavity.The female patient will be going to an oral surgeon to have the bur removed.The bur used was an ultrasharp diamond bur (087-9890) from (b)(4).

• Brand Name: IMPACT AIR 45
• Type of Device: HANDPIECE
• Manufacturer (Section D): PALISADES DENTAL, LLC; 111 cedar lane; englewood 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: 7616071
• MDR Text Key: 111610415
• Report Number: 3003963943-2018-00002
• 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: 06/19/2018

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: 7680
• 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: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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
• Patient Outcome(s): Required Intervention