MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER SHAP.21MM/S1 *NOT CE*; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A041022110112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a protaper shap.21mm/s1 *not ce* file broke during use.Reportedly, the broken part was retrieved.A few days later the patient complained of pain and sought medical care.X-ray was taken and it was found that there was a foreign object in the root canal which caused the pain.It was found that another piece of the file found in the buccal root canal.The patient requested to the doctor to ensure that the broken part removed.
Additional Manufacturer Narrative
Investigation summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1767307).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique (motor setting not communicated), overuse (number of uses not communicated), excessive wear, or material issue (no analysis of the broken fragments possible).Additional information received that the broken part that was found has been retrieved from the patient's tooth.This is a follow up report for this additional information.
Additional 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.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.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20555882
• Report Number: 8031010-2024-00129
• Device Sequence Number: 8961738
• Product Code: EKS
• UDI-Device Identifier: D716PTUHS1211
• UDI-Public: D716PTUHS1211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/04/2024

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: A041022110112
• Device Lot Number: 1767307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown