MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM; NEEDLE, DENTAL

Catalog Number XTIP50

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.This report is for the tenth device.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

It was reported that twelve x-tips broke during use; no injury resulted.

Manufacturer Narrative

Customer returned 14 unopened drill and guide sleeves.Visually inspected xtips under the microscope.No markings or manufacturer defects found.Customer did not indicate what part of the xtip was broken.Also, customer did not indicate at what speed the xtip was being used on.The direction for use indicates the xtips are to be used in a "slow speed 15,000 - 20,000 rpm hand piece".Customer did not return any broken xtips.Root cause is unknown since no broken xtips were returned.A dhr review was conducted with no discrepancies noted.

• Brand Name: X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM
• Type of Device: NEEDLE, DENTAL
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5698672
• MDR Text Key: 47741459
• Report Number: 2320721-2016-00014
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990511
• 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: 05/05/2016

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: XTIP50
• Device Lot Number: 0000095386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1