MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PATHFILE 21MM ASSORTMENT; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A001522190000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that pathfile 21mm assortment file bent during use.Reportedly, there was gingival bleeding.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are involved product that bent during use was not returned, and cannot be identified and analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1733716).Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Additional Manufacturer Narrative
Additional information received that the patient did not need any further medical or surgical treatment and they are fine.This is a follow up report for this information.Fda coding was missed in the initial report.Adding additional investigation conclusions code 4315.This is a follow up report to add this additional code.

• Brand Name: PATHFILE 21MM ASSORTMENT
• 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: 18100840
• Report Number: 8031010-2023-00863
• Device Sequence Number: 15383057
• Product Code: EKS
• UDI-Device Identifier: D716PTH0221ADEMO1
• UDI-Public: D716PTH0221ADEMO1
• 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): 11/22/2023

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?: No
• Device Catalogue Number: A001522190000
• Device Lot Number: 1733716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown