Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG GRUMME RONGEUR; RONGEUR, PRODUCT CODE: HTX
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FEHLING INSTRUMENTS GMBH & CO. KG GRUMME RONGEUR; RONGEUR, PRODUCT CODE: HTX Back to Search Results
Catalog Number NLU-2
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
Device still in hospital.
 
Event Description
During surgery the jaw of the ronguer (article number nlu-2, lot 12k356j, manufacturing year 2013) broke apart.As of our knowledge of today the fragment was removed completely.No part was left in the patient.
 
Event Description
This mdr is related to mdr 9615005-2017-80003.It's the follow-up with the final results of the investigation.According to report from hospital (event no.(b)(4), reported 01/22/2017) rongeur (article number nlu-2, lot 12k356j, manufacturing year 2013) broke during surgery which was noticed in css.Small metal peace was seen on x-ray.Ct scan confirmed metal retained.Incision was reopened at bedside.Fragment was retrieved.Retrieved fragment was smaller than the missing part from rongeur.Additional x-ray taken.No other metal was seen.
 
Manufacturer Narrative
Due to the reason that device was not returned for investigation we cannot perform a proper route cause analysis.All from our side possible investigations were made.In case we receive the damaged device we will open the case again.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GRUMME RONGEUR
Type of Device
RONGEUR, PRODUCT CODE: HTX
Manufacturer (Section D)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM  63791
MDR Report Key6339949
MDR Text Key68083965
Report Number9615005-2017-80003
Device Sequence Number1
Product Code HTX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberNLU-2
Device Lot Number12K356J
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-