MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART PLUS MOTOR; 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 Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device 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.Before use, the device won't hold file firmly.The engineer of the hospital found that the head part of device was worn, which led to can't hold file firmly.Equipment has been repaired.After the test performance is qualified, it has been returned to the doctor for normal use.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Event Description

In this event it was reported that a x-smart contra angle did not hold files; no injury resulted.

• Brand Name: X-SMART PLUS MOTOR
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 13506433
• MDR Text Key: 285733524
• Report Number: 8031010-2021-00197
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A100400000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1