MAUDE Adverse Event Report: DENTSPLY VDW GMBH BAUTELROCK ENLARGER; INTRAORAL DENTAL DRILL

Catalog Number S214300070201

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

In this event it was reported that an elargisseur (penetration drill) broke.The broken piece was not retrieved and was incorporated into the filling.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21 cfr 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.

Manufacturer Narrative

The returned enlargers are actually broken at the tip and in the middle of the active part.No material defect was found during analysis of the rupture pattern.No unused product is available for evaluation.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified.This kind of event is tracked and we monitor the trend.

• Brand Name: BAUTELROCK ENLARGER
• Type of Device: INTRAORAL DENTAL DRILL
• Manufacturer (Section D): DENTSPLY VDW GMBH; munich ; GM
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.,; ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4860128
• MDR Text Key: 15840958
• Report Number: 8031010-2015-00021
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S214300070201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other