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

Catalog Number 484004

Device Problem Unintended Ejection (1234)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Events meeting the definition of a serious injury are required to be reported.Therefore, because medical intervention was necessary to preclude permanent damage in this event, it does meet the criteria for reportability per 21 cfr part 803.Dimensional testing and pull testing demonstrated the chuck or the latching system was unable to produce the force specified.Normal wear could have caused the dimensions of the chuck to increase.This in turn could have caused the force the chuck normally holds on the bur to decrease to the point where the bur fell out.Quality personnel were unable to duplicate this due to the handpiece stalling when attempting to cut with the handpiece.

Event Description

In this event it was reported that a bur walked out of a handpiece and lacerated a patient's cheek.The laceration required a suture.

• Brand Name: MIDWEST QUIET-AIR L NON 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: 5773390
• MDR Text Key: 48916882
• Report Number: 1419322-2016-00162
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863677
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 484004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/06/2016
• 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
• Patient Outcome(s): Required Intervention