MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E HIGH SPEED ATTACHMENT 1:5 HS FO CA; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number 875005

Device Problems Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that the cap unscrewed from a midwest e handpiece while in use.The reported complaint did not result in an injury or need for intervention.

Manufacturer Narrative

As received, the attachment could support the reported complaint however, a root cause could not be determined.Production and quality testing of the attachment was not performed as the device was not in working condition.Microscopic evaluation revealed dent on the head.Based on the pictures there is the possibility that the attachment was dropped.The cap and set assemblies were detached from the head assembly.The bur end bearing was stuck inside head cavity.Attachment was sent to (b)(4) for further evaluation.Based on the results from (b)(4) the root cause for cap coming off could not be determine.Results from (b)(4) stated the housing of the head is damaged, the teeth are strongly worn, rust on the parts, contact between the cap button and pusher, no signs of loctite on the cap threads.Unable to determine the exact cause of the cap unscrewing, per (b)(4) evaluation damage to the head, debris and gear wear could be contributing factor.Possible chemical breakdown of the loctite.

• Brand Name: MIDWEST E HIGH SPEED ATTACHMENT 1:5 HS FO CA
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): SYCOTEC GMBH & CO KG; wangener strasse 78; leutkirch baden-wurttemberg, 88299 ; GM 88299
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5278880
• MDR Text Key: 33443530
• Report Number: 1419322-2015-00139
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 875005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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