MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG. CO., LLC; ULTRASONIC INSERT

Model Number UI30SD100

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The tip of the instrument broke in the patient's mouth, resulting in the opening of a flap to remove the fragmented piece.The reason as to the breakage of the insert is in process of being evaluated.Patient identifier is unknown.Age of patient is unknown.Sex of patient is unknown.Weight of patient is unknown.There are no relevant tests/laboratory data.There is no relevant history.Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture.The product involved in the event does not have an expiration date.The device is not implanted, therefore implant/explant dates are not applicable.No concomitant medical products and therapy dates provided.Device manufacture date is unknown.

Event Description

The dentist was using the instrument on a patient when the tip of the instrument broke in the patient's mouth.The doctor had to open a tissue flap in order to retrieve the broken piece.All broken pieces were retrieved.

Manufacturer Narrative

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: ULTRASONIC INSERT
• 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: 5985860
• MDR Text Key: 55875447
• Report Number: 1416605-2016-00006
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

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
• Device Operator: Dentist
• Device Model Number: UI30SD100
• Device Catalogue Number: UI30SD100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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