MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN INC; CARBIDE ROTARY DENTAL BUR

Model Number CSET02G10FZ775X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Eight (8) samples from the reported lot no were returned to prima dental group for evaluation.Visual inspection carried out by the qa dept confirmed all 8 to be in a good condition with no obvious signs of damage and/or deterioration.Using a calibrated 0-25mm external digital mircometer (asset no dm002, last calibrated 02/01/2019, calibration due date 05/01/2019), each of the 8 burs were measured in 2 places across the od of the shank.The results obtained are as shown below.Shank od specification - 1.590 to 1.600mm: sample #1 - 1.595/1.596, sample #2 - 1.595/1.596, sample #3 - 1.595/1.596, sample #4 - 1.595/1.596, sample #5 - 1.595/1.596, sample #6 - 1.595/1.596, sample #7 - 1.595/1.596, sample #8 - 1.595/1.596.As a secondary test the burs were checked for fit and performance using a ss white hand piece (e0151).In each case the burs locked securely into the hand piece and when tested on macor, a machineable glass ceramic, performed as per intended by the manufacturer.In order to ascertain more details about the procedure being conducted at the time of the reported incidents and the condition of the hand piece itself, a product deviation report (frm-12.A0) was sent to the importer for forwarding to the user.Unfortunately no details regarding the type and condition of the hand piece (ref service history) were provided.From the findings of our investigation we could find no fault with any of the burs returned in support of the complaint.The dhr for the lot no indicated no problems were experienced during the manufacturing process.

Event Description

While delivering a crown on a (b)(6) male patient, the entire bur fell out of the hand piece into the patients mouth.The patient swallowed the bur and was sent for an x-ray.The dr confirmed the patient was fine and no additional medical attention was required.The dr stated there were no changes in the patient's condition reported.

• Brand Name: HENRY SCHEIN INC
• Type of Device: CARBIDE ROTARY DENTAL BUR
• Manufacturer (Section D): PRIMA DENTAL GROUP; stephenson drive; gloucester, GL2 2 HA; UK GL2 2HA
• Manufacturer (Section G): PRIMA DENTAL GROUP; stephenson drive; gloucester, GL2 2 HA; UK GL2 2HA
• Manufacturer Contact: alan fowler ; stephenson drive; gloucester, GL2 2-HA ; UK GL2 2HA
• MDR Report Key: 8495603
• MDR Text Key: 141338238
• Report Number: 3003444492-2019-00001
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSET02G10FZ775X
• Device Catalogue Number: 900-4368
• Device Lot Number: 1165450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/22/2019
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 02/05/2019
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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): Hospitalization; Other
• Patient Age: 60 YR