MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ CONTRA ANGLE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number H105900000000

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This malfunction can cause 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.Unusual torque developed during rotation, since overhaul was not possible, a new handpiece was given to the customer.

Event Description

In this event it was reported that the torque of a x-smart iq applied by itself (improperly auto-reversing); no injury resulted.

• Brand Name: X-SMART IQ CONTRA ANGLE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city, tn
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 9885551
• MDR Text Key: 185231404
• Report Number: 8031010-2020-00048
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: K161213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H105900000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1