MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 774105

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Production personnel tested attachment and it passed all tests.The attachment was disassembled and microscopically evaluated for a potential cause of the reported temperature rise.Head cavity, cap end inner and outer races, and sheath joining area all exhibited slight debris.All drive gear components were slightly worn.All components were dry and lacked lubrication.It is possible that lack of lubrication may have caused friction and an accelerated wear condition for the internal components mentioned above.As a result, the tolerances between parts would tend to grow allowing more accelerated wear.1bis wear then could have led to friction and, in turn, possibly causing the heat that was reported in the original complaint.Vibration could have been caused by the wear observed in drive and head components.

Event Description

In this event a repair technician reported that a midwest estylus 1:5 attachment overheated.There was no injury or intervention.

• Brand Name: ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5958410
• MDR Text Key: 55001937
• Report Number: 1419322-2016-00240
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 774105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• 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