MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY #0/00 MORSE DE SCALER RESIN PURPLE; PERIODONTAL SCALER

Model Number SM0/00C8

Device Problem Material Fragmentation (1261)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, during a dental procedure, the tip of the instrument broke in the patient's gingiva.The broken tip was successfully removed by opening the gingiva.

Manufacturer Narrative

The device was returned to hu-friedy on (b)(4) 2014.The returned instrument was reviewed and it was determined that the returned instrument appears to have broken by applying a force higher than material capability to the working end and consequently resulting in breakage.Section a- weight sex, and age of patient is not known.Section d- hu-friedy does not track our devices, which are mostly low risk class i devices, by serial number, udi#, only a lot # 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 known.Section g, #5 all are not applicable.This is a class i exempt device.

• Brand Name: HU-FRIEDY #0/00 MORSE DE SCALER RESIN PURPLE
• Type of Device: PERIODONTAL SCALER
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 north rockwell st.; chicago IL 60618
• Manufacturer Contact: maria vrabie, director of ra ; 3232 north rockwell st.; chicago, IL 60618 ; 7738685676
• MDR Report Key: 3905051
• MDR Text Key: 22140925
• Report Number: 1416605-2014-00005
• Device Sequence Number: 1
• Product Code: EMN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SM0/00C8
• Device Catalogue Number: SM0/00C8
• Device Lot Number: 0114
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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