MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MIRROR - DBL SIDED, SZ 5; M52 - HYGIENE / PERIODONTAL

Catalog Number 67723

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

On 7/29/2016 ,integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - one mirror returned in used condition, showing minimal wear, scratched reflective surface and detached from frames.While inspecting the mirrors it is also noticed that the mirror is detached and have fallen out of frame.Without knowing what temperatures were used when in autoclave and how the mirror was handled during wiping; the cause is undetermined.This type of damage can happen when heat penetrates the reflective surface during autoclaving.The complaint report is confirmed.Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.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: issued on 6/7/2011 for the mirror glass becoming separated from the mirror frame; issued 12/28/2015 for double side mirror glass separating form the frame.Health hazard evaluation history: issued on 7/10/2009 for the following reasons: mirror detaching from the frame.Conclusion: the root cause has been identified as a workmanship or material deficiency.Appropriate action has been implemented to rectify this manufacturing deficiency.

Event Description

Customer initially reports mirrors are coming off of the surface, coming unglued.Fell off in patient's mouths.7/27/16 customer reports no harm done.This is 1 of 3 related complaints.

• Brand Name: MIRROR - DBL SIDED, SZ 5
• Type of Device: M52 - HYGIENE / PERIODONTAL
• 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: 5873646
• MDR Text Key: 52222843
• Report Number: 2523190-2016-00123
• Device Sequence Number: 1
• Product Code: EAX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67723
• Device Lot Number: M0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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