MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL EXCAVATOR DOUBLE ENDED USA 5; EXCAVATOR, DENTAL, OPERATIVE

Catalog Number 95-D-5

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that a excavator double ended usa 5 excavator tip broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

Investigation update: devices have been returned.The two returned excavators double ended usa 5 have each one broken active part.Breakages occurred at the base of the pallets.No material defect was found during analysis of the rupture patterns.Second active parts are not damaged.Nothing unusual to report was found during dhr review (batch #1749719).Root causes are not identified.We will track this kind of event and monitor the trend.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.This is to correct and remove the codes that were initially reported - removing codes for: type of investigation code - 4114.Removing code due to device being returned and inspected.

Manufacturer Narrative

Investigation summary: involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1749719).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: EXCAVATOR DOUBLE ENDED USA 5
• Type of Device: EXCAVATOR, DENTAL, OPERATIVE
• 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: 15924026
• MDR Text Key: 305927977
• Report Number: 8031010-2022-00703
• Device Sequence Number: 1
• Product Code: EKC
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 95-D-5
• Device Lot Number: 1749719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2022
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1