MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARB.BUR EXCAVAB.ROUND RA 014; BUR, DENTAL

Catalog Number E123A24101400

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that carb.Bur excavab.Round ra 014 broke during use.Outcome is unknown as of this mdr and additional information and product return requested.

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

Summary: returned carbide bur excavabur round ra 014 is actually broken at the brazing level (expected area).No material defect was found during analysis of the rupture pattern.Cutting edges are very worn out.No unused bur is available for evaluation.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.

Manufacturer Narrative

No product and no lot# available.No investigation or dhr review can be done.

• Brand Name: CARB.BUR EXCAVAB.ROUND RA 014
• 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: 15591354
• MDR Text Key: 301639856
• Report Number: 8031010-2022-00654
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup
• Report Date: 12/20/2022

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: E123A24101400
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/28/2022
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 09/28/2022
• Supplement Dates FDA Received: 11/14/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1