MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FORCEPS MCEN118 DIA 6.0MM VAUGHAN PUNCH; PFM11

Catalog Number MCEN118

Device Problems Break (1069); Component Falling (1105)

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

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for eval.An investigation has been initiated based on the reported info.

Event Description

During sinus surgery the mushroom punch from sinus accessory set broke off in pt's sinus.Noted from removal from the nose.Surgeon was able to retrieve the broken piece.On (b)(6) 2015 customer reports she has no knowledge of subsequent pt issues.

Manufacturer Narrative

Onn (b)(6) 2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.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.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.

• Brand Name: FORCEPS MCEN118 DIA 6.0MM VAUGHAN PUNCH
• Type of Device: PFM11
• 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; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4951724
• MDR Text Key: 23032591
• Report Number: 2523190-2015-00045
• Device Sequence Number: 1
• Product Code: GDF
• 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
• Reporter Occupation: Other
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCEN118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 79 YR