MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART IQ PROTAPER NEXT STARTER KIT; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number	A105420000000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a x-smart iq stops during use.No injury occurred.
Additional Manufacturer Narrative
Hdt here is bad motor handpiece as well.So, we can offer here 2 options - 1 - motor handpiece replacement for discounted price 2 - give old parts to contra-angle and cancel old unpaid invoice and invoice only diagnose.Failure mode - doesn't rotate / not running root cause - various mechanical problem conclusion code - indeterminable.

• Brand Name: X-SMART IQ PROTAPER NEXT STARTER KIT
• Common Device Name: CONTROLLER, FOOT, HANDPIECE AND CORD
• 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: 22307378
• Report Number: 8031010-2025-00102
• Device Sequence Number: 8621136
• Product Code: EBW
• UDI-Device Identifier: D716XSIQEM1BSK1
• UDI-Public: D716XSIQEM1BSK1
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/16/2025

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: A105420000000
• Device Lot Number: 05527 / 1296916135468
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown