MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR; HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number A100400000000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

In this event it is reported that x-smart w/contra angle eur won't hold files.No injury resulted.

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.Investigation results: casting assy.Broken, cartridge lock is broken, head cap weak, replaced casting assy., cartridge, and head cap.

Manufacturer Narrative

No product has been returned after 3 documented attempts.Complaint will be reopened if suspect product arrives per 8000-sop-038.

• Brand Name: X-SMART W/CONTRA ANGLE EUR
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• 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: 15649769
• MDR Text Key: 302874761
• Report Number: 8031010-2022-00656
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K990682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A100400000000
• Device Lot Number: 0V937750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/07/2022
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1