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

Catalog Number C021220021000

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.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that a penetration drill separated after one use; no injury resulted.

• Brand Name: SPECIAL PENETRATION DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7729400
• MDR Text Key: 115374830
• Report Number: 8031010-2018-00072
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C021220021000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1