MAUDE Adverse Event Report: HENRY SCHEIN INC. HENRY SCHEIN; HIGH SPEED DENTAL HANDPIECE

Model Number C-TYPE MINI

Device Problems Use of Incorrect Control/Treatment Settings (1126); Fail-Safe Design Failure (1222)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Improper maintenance.Raw pull force before cleaning is 5.5 lbs.And after cleaning is 7.4 lbs.Debris found inside the autochuck.Recommend raw pull force per iso standard is 6.2 lbs.Minimum.Other potential contributed factors: excessive air pressure and speed.Excessive air pressure and over speed limit can cause slippage of the bur.Bur extension: dental bur does not fully insert into autochuck may cause slippage.( send autochuck to manufacture for further investigation).Bur shank is under size: per iso standard, the dental bur diameter must be 1.6mm +0.000/-0.002mm.(we do not have the dental drill that was used on this handpiece when the incident occurred).

Event Description

Bur flew out of handpiece and went down to patient throat.

• Brand Name: HENRY SCHEIN
• Type of Device: HIGH SPEED DENTAL HANDPIECE
• Manufacturer (Section D): HENRY SCHEIN INC.; 135 duryea road; melville NY 11747
• Manufacturer Contact: timothy ropchan ; 602 s. placentia ave.; placentia, CA 92870 ; 7145790175
• MDR Report Key: 7275592
• MDR Text Key: 100523938
• Report Number: 3007007357-2018-00001
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040058213
• UDI-Public: 00304040058213
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: C-TYPE MINI
• Device Catalogue Number: 112-7299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 82