MAUDE Adverse Event Report: INTEGRA YORK PA, INC. SCHEIN K-FILE 21 MM SZ 25; M50 - ENDODONTICS

Catalog Number 1123753

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Customer initially reports file broke during a root canal.On (b)(6) 2015, customer reports that it was two size 25 files that broke while in use on the same patient.Piece remains in canal.No harm exhibited so far.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: SCHEIN K-FILE 21 MM SZ 25
• Type of Device: M50 - ENDODONTICS
• Manufacturer (Section D): INTEGRA YORK PA, INC.; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise dr.; 6099366828
• MDR Report Key: 4425434
• MDR Text Key: 16179956
• Report Number: 2523190-2015-00001
• Device Sequence Number: 1
• Product Code: EKS
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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: 1123753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 01/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR