MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL XT; SCALER, ULTRASONIC

Model Number	UI25SSXT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no relevant history.Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number, only by a lot number, which is tied to the date of manufacturer.The device is not implanted, therefore implant/explant dates are not applicable.Re-processor does not apply.Concomitant medical products: no known concomitant medical products and therapy dates.User facility/importer does not apply.Ind is not applicable.
Event or Problem Description
Tip broke off of ultrasonic insert while hygienist performed scaling and root planning.The office believes the broken tip was suctioned away during the procedure.

• Brand Name: SWIVEL XT
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8191686
• Report Number: 1416605-2018-00010
• Device Sequence Number: 2118981
• Product Code: ELC
• UDI-Device Identifier: 10889950075514
• UDI-Public: (01)10889950075514(10)0918
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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
• Operator of Device: Health Professional
• Device Model Number: UI25SSXT
• Device Catalogue Number: UI25SSXT
• Device Lot Number: 0918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR