MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ROOT ELEVATOR BK CV3.5MM; M51 - GENERAL DENTISTRY

Catalog Number DELB4

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 01/11/2016

Event Type  malfunction  

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.

Event Description

Customer initially reports delb4 tip broke after 2nd use.(b)(6) 2016 doctor reports he was removing wisdom teeth, no harm done, tip easily retrieved.

Manufacturer Narrative

(b)(6) 2016 integra investigation completed.Failure analysis, device history evaluation.Failure analysis - elevator returned in used condition, not showing any unusual markings and a broken tip.Without knowing how much pressure was used and what angle of the elevator to the tooth during leveling, excess force applied to the tips of the instrument may have led to the tips breaking.This type of damage is typically the result of improper usage.The damage to the elevator is not identified as a workmanship or material deficiency.The complaint report is confirmed.Device history evaluation: nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none health hazard evaluation history: none the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: ROOT ELEVATOR BK CV3.5MM
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5418025
• MDR Text Key: 37727555
• Report Number: 2523190-2016-00008
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

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: DELB4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR