MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY SWIVEL DIRECT FLOW INSERT, #100 THIN; SCALER, ULTRASONIC

Model Number UI30SD100

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Hu-friedy does not track this device by serial number, only by a lot number which is tied to the date of manufacture.The device involved does not have an expiration date.The device is not implanted, therefore implant/explant dates are not applicable.Reprocessor does not apply.No known concomicant medical products and therapy dates.User facility/importer does not apply.Ind is not applicable.This is an initial report.

Event Description

During a scaling procedure, the instrument tip broke in the patient's mouth.It was initially unknown whether the patient had swallowed the tip, or whether the tip was suctioned.The patient underwent a chest x-ray and it was confirmed that the tip had either not been swallowed, or had already passed.

• Brand Name: HU-FRIEDY SWIVEL DIRECT FLOW INSERT, #100 THIN
• 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: 7189885
• MDR Text Key: 97864650
• Report Number: 1416605-2018-00001
• Device Sequence Number: 1
• Product Code: ELC
• 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: distributor,health profession
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: 0417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 52 YR