MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL UNK MAILLEFER; BUR, DENTAL

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/27/2023

Event Type  malfunction  

Event Description

In this event it is reported that carbide bur broke during use and the broken part was swallowed by the patient.The patient went to the hospital and the patient is fine.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Manufacturer Narrative

No product and no lot# available.No investigation or dhr review can be done.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: UNK MAILLEFER
• 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: 17377293
• MDR Text Key: 319611622
• Report Number: 8031010-2023-00820
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1