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 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 1:5 handpiece while in use.The reported complaint did not result in an injury or need for intervention.

Manufacturer Narrative

Dentsply was able to support the complaint by the condition the attachment was received in.After microscopic investigation, it was noted the threads had debris and some slight signs of corrosion were present.The cap end bearing was broken into pieces.The bur end bearing was stuck inside the head cavity.Attachment was sent to sycotec for further evaluation.Results from sycotec stated: set assembly is broken into pieces.Gears are worn.All parts are very dirty, worn and dry.

• 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: 5865917
• MDR Text Key: 52442093
• Report Number: 1419322-2016-00210
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• 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