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 Component (1104); Device Dislodged or Dislocated (2923)

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 1:5 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.The attachment was then microscopically evaluated by quality personnel.Both bearings were detached from the set assembly.The bur end bearing outer race was stuck inside the head cavity.Both bearing retainers looked good with no evidence of wear.Some debris was observed inside head cavity.Cap cavity looked good.Minor wear was observed on the head gears.Some debris was also observed within the cap and head threads.The bur was rusted as received.Contact was also seen between cap button and pusher.Attachment was sent to sycotec for further evaluation.Results from sycotec stated: the head housing shows strong damage and deformations, presumably from a fall.The key surface from the push button shows dents.The inner side of the push button and also the surface of the pressure pieces shows heavy seizing marks, this is a sign that both had contact while running.The teeth of the drive shaft and also the cartridge are heavily worn.The surface of the inner and outer ring from the ball bearing shows also traces of wear.The balls are missing.

• 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: 6394099
• MDR Text Key: 69869837
• Report Number: 1419322-2017-00028
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• 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: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1