MAUDE Adverse Event Report: HU-FRIEDY MFG. CO.,LLC. #152 CUMINE DE SCALER, #6 HD1

Model Number SCM1526

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, during a procedure to remove a tooth, a hu-friedy scaler broke inside the patient's mouth.A foreign object was found in the patient's left maxillary sinus.The patient was hospitalized between (b)(6) 2014.The foreign object was removed through the maxillary sinus via surgery.It was reported that the post surgical process was without complications.A follow up appointment was made to remove the sutures.

Manufacturer Narrative

The broken device without the tip was returned to hu-friedy on (b)(4) 2014.The returned device was reviewed and the device appeared to be old and worn.The unbroken working end had a dull cutting edge.The dull condition of the instrument appears to have contributed to applying a force higher than material capability to the working end and consequently resulting in breakage.Additionally, these types of scalers have a normal life expectancy of up to 9 months.This instrument was manufactured in january 2011.Weight and age of patient is not known.Hu-friedy does not track our devices, which are mostly low risk class i devices, by serial number, 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 applicable.The initial reporter's email address is not known.All are not applicable.This is a class i exempt device.

• Brand Name: #152 CUMINE DE SCALER, #6 HD1
• Type of Device: 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: 4173060
• MDR Text Key: 5090806
• Report Number: 1416605-2014-00006
• 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: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCM1526
• Device Catalogue Number: SCM1526
• Device Lot Number: 0111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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
• Treatment: NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES; REPORTED
• Patient Outcome(s): Hospitalization; Other