MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SCHEIN, AUTOCL U CONTRA A; M51- GENERAL DENTISTRY

Catalog Number 1005848

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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

Patient initially reports screw comes out of the head of the angles.On (b)(6) 2015 customer reports screws fell out when doctor was working with device on a tray, no patient contact at the time, no further information available.Customer fears screws could have fallen off in patient mouth.

Manufacturer Narrative

On 9/4/2015 integra investigation completed.Method: failure analysis, device history evaluation.Manufacture date unknown.Results: failure analysis: there were two contra angles in used condition, not showing any unusual markings.Upon the evaluation of the angle it is confirmed that the screw has fallen off.Without knowing how the instrument was maintained and handled, the cause of the complaint report is undetermined.It is possible the screw fell out due to the vibration to the instrument causing the screws to loosen; eventually falling out.Device history evaluation: dhr review was completed with all history available.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: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: SCHEIN, AUTOCL U CONTRA A
• Type of Device: M51- GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 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: 5011828
• MDR Text Key: 24224976
• Report Number: 2523190-2015-00049
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1005848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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