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.
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