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

Catalog Number 1005848

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 07/03/2015

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 upon the reported information.

Event Description

Customer initially reports screw popped off.On (b)(6) 2015 doctor uses rubber dam to prevent pt from swallowing things, no harm done.

Manufacturer Narrative

On (b)(6) 2015 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - a contra angle was returned in used condition, not showing any unusual markings.Device is showing wear, residue and broken screw top.Upon the evaluation of the angle it is confirmed that the screw has fallen off.It also appears to have built up residue on the screw area.Without knowing how the instrument was maintained and handled, the cause of the complaint report is undetermined.This type of damage is typically the result of improper processing.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.; 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: 4996017
• MDR Text Key: 23840170
• Report Number: 2523190-2015-00047
• Device Sequence Number: 1
• Product Code: EFB
• 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: 07/16/2015,08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• 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: 07/23/2015
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 07/16/2015
• Date Manufacturer Received: 08/11/2015
• 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
• Patient Age: 39 YR