MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS MCEN42 100MM CVD LFT ROUVIER; PFM11

Catalog Number MCEN42

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

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

It was reported that during a lateral right ethmoidectomy, the device blade broke in the sinus.The broken part was retrieved with no consequences on the patient however, physician think that there was a risk of injury when the broken blade was retrieved.The surgery was completed with another device and the event lead to surgical delay, unknown for how long.

Manufacturer Narrative

Integra has completed their internal investigation on december 27, 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: evaluation of returned device; product or objective evidence was returned and the evaluation verified the complaint as valid.The fixed blades is broken at pin location.The aspect is different from manufacturing specifications.A thorough observation of the breakage area revealed oxidized material.Dhr review; no anomalies that could be associated with the complaint were observed.Complaints history; first occurrence for this risk for this device - no adverse trend.Conclusion: the instrument was not serviced by the manufacturer since its first use.However it has been modified by an external contractor no qualified by the manufacturer.This modification could have weakened the instrument and led to the reported event.

• Brand Name: SCISSORS MCEN42 100MM CVD LFT ROUVIER
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6191713
• MDR Text Key: 63319893
• Report Number: 2523190-2016-00207
• Device Sequence Number: 1
• Product Code: KBD
• 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: Audiologist
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCEN42
• Device Lot Number: 201207MF2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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 Outcome(s): Other
• Patient Age: 78 YR