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

Catalog Number C226U00000800

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device 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.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

In this event it was reported that a drill from the uni-clip set broke during first use; no injury resulted.

Manufacturer Narrative

The returned drill has broken in the ground part.No material defect was found during analysis of the rupture patterns.No unused largo was returned for evaluation.Nothing unusual to report was found during dhr review.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: UNICLIP DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 7730100
• MDR Text Key: 115533003
• Report Number: 8031010-2018-00077
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

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: C226U00000800
• Device Lot Number: 1451664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/29/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1