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

Model Number	UI30SD100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight of patient is unknown.There is no relevant history.The device is not implanted, therefore implant/explant dates are not applicable.Reprocessor does not apply.No known concomitant medical products and therapy dates.User facility/importer does not apply.
Event or Problem Description
During a dental cleaning the tip of an instrument broke off in the patient's mouth and could not be located.

• Brand Name: SWIVEL DIRECT FLOW INSERTS
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8246458
• Report Number: 1416605-2019-00002
• Device Sequence Number: 2198752
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: (01)10889950075620(10)0916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: 0916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/14/2019
• 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: Hospitalization
• Patient Age: 20 YR