MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARB.B.CAV.CONE SQUARE FG 012; BUR, DENTAL

Catalog Number E013834101200

Device Problem Break (1069)

Patient Problems Pain (1994); Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

In this event it is reported that carb.B.Cav.Cone square fg 012 broke during use and stabbed the patient's oral mucosa causing bleeding and pain.Outcome of this event is unknown as of this mdr and further information requested.

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 #1667603).Root causes are not identified.We will track this kind of event and monitor the trend.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Manufacturer Narrative

Additional information has been received for this event since the last submitted mdr.We received the following information regarding this complaint 1.The patient is fine now.2.No follow-up treatment.3.The broken part has been retrieved.4.The broken file can't be found to return.The investigation results are.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 #1667603).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: CARB.B.CAV.CONE SQUARE FG 012
• 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: 15933365
• MDR Text Key: 304994211
• Report Number: 8031010-2022-00707
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: E013834101200
• Device Lot Number: 1667603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/29/2022
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female