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

Catalog Number 790045

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 came in missing a cartridge with the exception of one bearing.Score marks and some debris were observed inside the head cavity.Cap exhibited some scratches/tool marks on its surface.Cap cavity looked good with only minor debris.The retainer exhibited significant horizontal wear.Debris was observed within the returned outer race.Bearing failure could have increased vibration and instability within the head cavity causing the cap to unscrew.Due to the cap turning itself in both directions may have cause wear on the head threads.There is a possibility that the thread issue was a manufacturing error but a review of the dhr documents for the lots before and after as well as this lot did not show any issues, therefore we assume that the head thread being out of specification was due to the cap unscrewing during use.

Event Description

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

• Brand Name: MIDWEST TRADITION PB 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: 6424173
• MDR Text Key: 70640346
• Report Number: 1419322-2017-00047
• 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
• Type of Report: Initial
• Report Date: 03/22/2017

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: 790045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/22/2017
• 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: Reuse
• Patient Sequence Number: 1