MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARBIDE BUR CAVITY ROUND FG008; BUR, DENTAL

Catalog Number 123-FG19-008

Device Problem Break (1069)

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

In this event it is reported that carbide bur cavity round fg008 broke during use.The failure of the device caused bleeding in the gums of the patient.Measurements were taken to stop bleeding and the bleeding was stopped.The broken device was disposed of as medical waste.

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Manufacturer Narrative

Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused bur is available for evaluation.Nothing unusual to report was found during dhr review (batch #1736624).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: CARBIDE BUR CAVITY ROUND FG008
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15649980
• MDR Text Key: 303437099
• Report Number: 8031010-2022-00660
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 123-FG19-008
• Device Lot Number: 1736624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/11/2022
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male