MAUDE Adverse Event Report: RADIX ANCHOR DRILLS ROOT FACER; INSTRUMENT, DIAMOND, DENTAL

Catalog Number C021720000100

Device Problem Break (1069)

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

Event Type  malfunction  

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.Nothing unusual to report was found during dhr review (batch #1661113).The three returned root facers radix 1 have no visual damage, seem unused.The involved drills which have broken during treatment have not been returned and cannot be analyzed.Notably, the place where the breakages occurred remains uncertain.No test is applicable on the root facers radix 1.Root causes are not identified.We will track this kind of event and monitor the trend.For information, the pivot part diameters have been measured and are matching to the drawing.Generally speaking, the root facers must be used only in a straight line, without giving bending movement.

Event Description

In this event it was reported that a radix root facer separated during use.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information was received indicating that the broken piece was retrieved, and no injury resulted.Nothing unusual to report was found during dhr review (batch #1661113).The three returned root facers radix 1 have no visual damage, seem unused.The involved drills which have broken during treatment have not been returned and cannot be analyzed.Notably, the place where the breakages occurred remains uncertain.No test is applicable on the root facers radix 1.Root causes are not identified.We will track this kind of event and monitor the trend.For information, the pivot part diameters have been measured and are matching to the drawing.Generally speaking, the root facers must be used only in a straight line, without giving bending movement.

• Brand Name: RADIX ANCHOR DRILLS ROOT FACER
• Type of Device: INSTRUMENT, DIAMOND, DENTAL
• MDR Report Key: 11382990
• MDR Text Key: 234995979
• Report Number: 8031010-2021-00023
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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 Operator: No Information
• Device Catalogue Number: C021720000100
• Device Lot Number: 1661113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1