MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL C+FILE READYSTEEL 21MM ASS; FILE, PULP CANAL, ENDODONTIC

Catalog Number	670AS21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional 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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a c+file readysteel 21mm ass broke during use.The broken part remains in the root canal.Further information requested.
Additional Manufacturer Narrative
Additional information received that no patient injured, and all the broken parts retrieved from the patient mouth.Since this is the case the 8000-opn-011 applies (broken parts retrieved - no patient's injury) applies to this event and is not reportable.Please disregard the initial report.

• Brand Name: C+FILE READYSTEEL 21MM ASS
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• 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: 19069513
• Report Number: 8031010-2024-00030
• Device Sequence Number: 4658285
• Product Code: EKS
• UDI-Device Identifier: D716670AS211
• UDI-Public: D716670AS211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 670AS21
• Device Lot Number: 1716365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown