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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH PFM11

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INTEGRA MICROFRANCE S.A.S. FORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH PFM11 Back to Search Results
Catalog Number MCEN116
Device Problem Break
Event Date 04/03/2018
Event Type  Malfunction  
Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

 
Event Description

A field sales manager reported on behalf of the customer that on (b)(6) 2017, the tip of the mcen116 forceps mcen116 dia 4. 0mm vaughan punch was broken. The product was placed in position at sphenoid face and a bite was attempted on the medical sphenoid face. The bone was fairly thin but the tip broke instantly and fell into the sphenoid sinus. However, no patient injury, no medical revision or intervention was done and no delay in surgery was reported. Additional information has been requested but no other clinical information has been provided.

 
Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed. The serial/lot number was not provided therefore a dhr review and investigation could not be performed.

 
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Brand NameFORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH
Type of DevicePFM11
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
kimberly shelly
311 enterprise drive
plainsboro , NJ 08536
6099362393
MDR Report Key7487823
Report Number2523190-2018-00068
Device Sequence Number1
Product CodeKAY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMCEN116
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
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 Unkown

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