MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION FIBER OPTIC; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 750045

Device Problem Detachment Of Device Component (1104)

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.As received, the handpiece could support the reported complaint however, a root cause could not be determined.Production and quality testing of the handpiece was not performed as the device was not in working condition.Multiple dimensions on the head were checked by production personnel.The handpiece was then microscopically evaluated by quality personnel.Microscopic evaluation revealed significant debris within the head cavity.Some rubbing marks were also seen within the head cavity.The evaluation also revealed damage to the rotor blades.The bur end bearing was loose.Loose bearing plus the use of a large headed bur could have increased vibration within the head cavity due to an already unstable set assembly, causing the cap to unscrew but this could not be confirmed.

Event Description

In this event it was reported that a cap came off a tradition handpiece during a procedure.The reported complaint did not result in an injury or need for intervention.

• Brand Name: MIDWEST TRADITION FIBER OPTIC
• 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: 5053443
• MDR Text Key: 25537779
• Report Number: 1419322-2015-00089
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 750045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• 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