MAUDE Adverse Event Report: COLTENE WHALEDENT INC. BIOSONIC; ULTRASONIC SCALER TIP

Model Number	US1030KOS
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Scaler tip broke during procedure.
Additional Manufacturer Narrative
The tip of the inset has broken off, this may be due to a manufacturing defect during manufacturing, or it could be a defect in the material from an outside supplier.There is also the possibility of customer abuse, the insert may have been used as a pick to remove material.(b)(4).Low power unit: low power setting: 8.4w, 29,009hz.High power setting 31.4w, 29,025hz.High power unit: low power setting: 17.7w, 29,078hz.High power setting: 31.7w, 29,073hz.Spray, good at how power only.Solder joint, 3/16".Task for (b)(4): quality department: status: task completed; follow-up action completed.Review complaint.06/23/2018 21:03:41 cet (b)(4), risk is negligible, no capa required.Risk/capa assessment: 09/07/2018 15:52:48 cet (b)(4) complaint history was reviewed in sap.The part was manufactured in january 2018.This complaint is the only instance of a tip breaking for this part number between january 2017 and january 2018.Risk assessment: probability: remote.Severity: minor.Risk: minimal.Capa required: no (isolated incident to one customer).

• Brand Name: BIOSONIC
• Common Device Name: ULTRASONIC SCALER TIP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808551
• Report Number: 2416455-2018-08234
• Device Sequence Number: 1012638
• Product Code: ELC
• UDI-Device Identifier: D661US1030KOS0
• UDI-Public: D661US1030KOS0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K983727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: US1030KOS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1