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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH CERAMO RONGEUR WITH EJECTOR

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FEHLING INSTRUMENTS GMBH CERAMO RONGEUR WITH EJECTOR Back to Search Results
Model Number NNN-2S
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 04/19/2016
Event Type  malfunction  
Event Description
This mdr is related to (b)(4). It was reported that a ceramo rongeur break during surgery. According to the lot nr. And to the pictures: the ceramo rongeur with ejector nnn-2s (40° aufw. , 3,0 x 200 mm) has been in use for a bit less than 4 years. The different screws of the seem very used. The smaller screw on the shaft of the bone punch seems to have been "rebuilt". We asset that the bigger screw had been rebuilt too, in order to make out of an non-detachable rongeur a detachable one. The thread of the screw might have been damaged from the dis- and reassembly over the years. This special rongeurs are not detachable, they are to be cleaned and sterilized without prior disassembly. Measures: when the damage instrument arrived further investigation will be conducted to confirm or not the previous observation.
 
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Brand NameCERAMO RONGEUR WITH EJECTOR
Type of DeviceCERAMO RONGEUR
Manufacturer (Section D)
FEHLING INSTRUMENTS GMBH
hanauer landstrasse 7a
karlstein, bavaria 63791
GM 63791
MDR Report Key5811525
MDR Text Key280443395
Report Number9615005-2016-80002
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Model NumberNNN-2S
Device Catalogue NumberNNN-2S
Device Lot NumberX11M556
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/21/2016 Patient Sequence Number: 1
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