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

Model Number UI30SD100

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  Injury  

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 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
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 8246458
• MDR Text Key: 133059486
• Report Number: 1416605-2019-00002
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: (01)10889950075620(10)0916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 20 YR