MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SA GATES GLIDDEN DRILL; INTRAORAL DENTAL DRILL

Catalog Number 12330020009

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event, it was reported that a gates drill separated.The separated piece was retrieved and no injury resulted.

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 possible 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.The device is available for eval, though results are not available as of this report.Eval results will be submitted as they become available.

Manufacturer Narrative

Returned product has been analyzed and turns out to be counterfeit.Instruments do not meet maillefer standard quality.Labels are also copied (the printed batch number has no corresponding in our erp system with the (catalog #a000824000212 but rather with the catalog #a000824000112).

• Brand Name: GATES GLIDDEN DRILL
• Type of Device: INTRAORAL DENTAL DRILL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SA; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w philadelphia st; susquehanna commerce ctr w, ste 60, ; york, PA 17401 ; 7178457511
• MDR Report Key: 4862567
• MDR Text Key: 5851607
• Report Number: 8031010-2015-00022
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12330020009
• Device Lot Number: 1668500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• 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