MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FORCEPS MCEN27-2 PEDIATRIC BACKBITER; PFM11

Catalog Number MCEN27-2

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)

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

Event Date 08/12/2015

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 on the reported information.

Event Description

Customer initially reports the hinged jaw cup broke off in the nasal cavity during a septoplasty surgery.(b)(6) 2015 customer reports no harm done.

Manufacturer Narrative

On 10/7/15 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed/no return of device 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: none.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.Product has not been returned for evaluation.

• Brand Name: FORCEPS MCEN27-2 PEDIATRIC BACKBITER
• 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; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5061593
• MDR Text Key: 25881190
• Report Number: 2523190-2015-00076
• Device Sequence Number: 1
• Product Code: KAE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCEN27-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• 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: 33 YR