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

Model Number UI25SSXT

Device Problem Material Fragmentation (1261)

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

Event Date 11/14/2018

Event Type  malfunction  

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 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
• 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
• MDR Report Key: 8191686
• MDR Text Key: 131496393
• Report Number: 1416605-2018-00010
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075514
• UDI-Public: (01)10889950075514(10)0918
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• 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): Other
• Patient Age: 40 YR