MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROPEX PIXI EUR; LOCATOR, ROOT APEX

Catalog Number	A103000000100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a propex pixi eur was giving incorrect measurements.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
While no serious injury resulted in this event, 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.
Additional Manufacturer Narrative
Dentsply sirona uk.Engineer's findings: 'the customer has advised that the back casing is broken and that the device is not providing accurate readings, the measuring cable, charger and file clips haven't been sent in for a full assessment to be carried out.Unit set up and evaluated, upon inspection both the front and rear casings were damaged and so both cases were replaced along with a new aaa rechargeable battery.Battery charged overnight and unit tested at 3 depths using our test equipment with the device responding successfully.

• Brand Name: PROPEX PIXI EUR
• Common Device Name: LOCATOR, ROOT APEX
• 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: 21584557
• Report Number: 8031010-2025-00025
• Device Sequence Number: 9467438
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: A103000000100
• Device Lot Number: PX2018104057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown