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

Catalog Number MCEN116

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: FORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7487823
• MDR Text Key: 107588187
• Report Number: 2523190-2018-00068
• Device Sequence Number: 1
• Product Code: KAY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCEN116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• 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: Unknown
• Patient Sequence Number: 1