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

Model Number	C-TYPE MINI
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Fail-Safe Design Failure (1222)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Bur flew out of handpiece and went down to patient throat.

• Brand Name: HENRY SCHEIN
• Common Device Name: HIGH SPEED DENTAL HANDPIECE
• Manufacturer (Section D): HENRY SCHEIN INC.; 135 duryea road; melville NY 11747
• MDR Report Key: 7275592
• Report Number: 3007007357-2018-00001
• Device Sequence Number: 1824066
• Product Code: EFB
• UDI-Device Identifier: 00304040058213
• UDI-Public: 00304040058213
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 82