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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWDEAL SAS UNKNOWN FOREFOOT SET; N/A
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NEWDEAL SAS UNKNOWN FOREFOOT SET; N/A Back to Search Results
Catalog Number XXX-FOREFOOT SET
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
It was reported that on (b)(6) 2019, some drills of the forefoot set have important traces of residues inside the hollow bodies and there were also traces on supports.
 
Manufacturer Narrative
Failure analysis: due to the unavailability of kits in the warehouse, 2 kits were transferred from one facility to another facility for specific surgery.The sets were neither inspected nor decontaminated by trained integra employees.The standard travel set process was not followed.Dhr: set was not returned to the kitting centre for inspection/ decontamination.Hence dhr does not need to be reviewed.1 of 2 reports.Other mfg report number: 9615741-2019-00010.
 
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Brand Name
UNKNOWN FOREFOOT SET
Type of Device
N/A
Manufacturer (Section D)
NEWDEAL SAS
97 allee alexandre borodine
97 allee alexandre borodine
saint priest 69800
FR  69800
MDR Report Key8630146
MDR Text Key146380634
Report Number9615741-2019-00009
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K093914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-FOREFOOT SET
Was Device Available for Evaluation? No
Date Manufacturer Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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