MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. DRILL BURR 7777 DIA 2.0MM LEMOINE; PFM11

Catalog Number 7777

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 08/24/2015

Event Type  Injury  

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

The drill burr for lemoine drill broke in patient sinus.There are no other consequences for the patient, except for the broken part in the sinus.(b)(6) 2015: patient: cannot have mris.The surgeon left the broken part in the patient because there was a risk to damage the sinus.

Manufacturer Narrative

Integra has completed their internal investigation on 09/15/2015.The investigation included: methods: evaluation of actual device.Results: evaluation of returned device; the drill bit is broken.The fragment of about 1cm length stayed in the patient.The mobile part which screw has not been returned.Rod length, threaded rod length, washer knurling, proximal part form and drill bit assembling do not meet the manufacturing specifications.Lot number and manufacturing date unknown.Conclusion: this device is not an integra (microfrance) instrument.

• Brand Name: DRILL BURR 7777 DIA 2.0MM LEMOINE
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5064851
• MDR Text Key: 25305244
• Report Number: 2523190-2015-00079
• Device Sequence Number: 1
• Product Code: EQJ
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• 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 Outcome(s): Other