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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWDEAL SAS AO DRILL 2 IN 1 DIAM 2.2MM L 22MM CANNULATED N/A

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NEWDEAL SAS AO DRILL 2 IN 1 DIAM 2.2MM L 22MM CANNULATED N/A Back to Search Results
Catalog Number 159025SND
Device Problem Product Quality Problem
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

The 2 of 2 reports: other mfg report number: 9615741-2017-00041. It was reported that the physician used the new ff2 consignment for the first time. When using the 2 in 1 drill (ref (b)(4)); both drills didn't seem sharp enough and seemed ineffective. She had to open the old ff consignment and use the drills of this set. Product was in contact with the patient; however, no patient injury was reported and the event lead to 10 minutes surgical delay.

 
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Brand NameAO DRILL 2 IN 1 DIAM 2.2MM L 22MM CANNULATED
Type of DeviceN/A
Manufacturer (Section D)
NEWDEAL SAS
97 allee alexandre borodine
97 allee alexandre borodine
saint priest 69800
FR  69800
Manufacturer (Section G)
NEWDEAL SAS
97 allee alexandre borodine
parc tech de laporte des alpes
saint priest 69800
FR  69800
Manufacturer Contact
sonia irizarry
311 enterprise drive
plainsboro , NJ 08536
6099362393
MDR Report Key7127710
Report Number9615741-2017-00042
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number159025SND
Device LOT NumberFDKF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2015
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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