MAUDE Adverse Event Report: INTEGRA YORK, PA INC EXTR FCPS, GRIP DEEP MD4; M51 - GENERAL DENTISTRY

Catalog Number DEFDGMD4

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

Customer initially reports bottom part of forcep broke off the device broke during an extraction.There was no harm to the pt, the broken piece was easily retrieved.There are no further details available because the event occurred over a month ago.

Manufacturer Narrative

The device involved in the reported incident has been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: EXTR FCPS, GRIP DEEP MD4
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4093173
• MDR Text Key: 4715634
• Report Number: 2523190-2014-00054
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2014

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: DEFDGMD4
• Device Lot Number: 00283554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/21/2014
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1