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 21 cfr part 803.This report is for the third 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 three x-tips broke during use; no injury resulted.

Manufacturer Narrative

Customer returned 50 unopened drill and guide sleeves for lot number 115742 and 6 up opened drill and guide sleeves from previous lot number that had expired on 05 15.No bent, broken, or opened product was returned.Unknown which lot customer was referring to in the complaint.No testing performed on expired product.Using the ansi plan with and aql of 1.5 using normal sample plan randomly selected and tested 8 pieces from the lot number with non expired product.Using microscope visually checked drills.No manufacturing defects or markings noted on drills.Using test method tm-0009 for the go ring gauge.All 8 tested passed the through the go ring gauge.Tested drills using a push button contra angle and drills fit into the contra angle with no hesitation.No fault found with returned drills.

• 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: 6031575
• MDR Text Key: 57717641
• Report Number: 2320721-2016-00056
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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: 0000115742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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