MAUDE Adverse Event Report: DENTSPLY MAILLEFER GATES GLIDDEN DRILL; DRILL, DENTAL, INTRAORAL

Catalog Number A000823000100

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

In this event it was reported that a gates drill separated during use and the dentist could not retrieve the separated piece.The pt was referred to an endodontist for removal of the separated piece.

Manufacturer Narrative

Because evaluation of the unit involved is not complete as of this report and since this issue could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the device malfunctioned and that the malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The doctor had several lots of drills and was unsure which lot the device belonged to.Three lots were reported: 9450220, 0411800, and 9202910.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

• Brand Name: GATES GLIDDEN DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st, ste 60; susquehanna commerce center w; york, PA 17401 ; 7178457511
• MDR Report Key: 3929001
• MDR Text Key: 16447001
• Report Number: 8031010-2014-00006
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A000823000100
• Device Lot Number: 9450220
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention