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

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.

• Brand Name: CERAMO RONGEUR WITH EJECTOR
• Type of Device: CERAMO RONGEUR
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH; hanauer landstrasse 7a; karlstein, bavaria 63791 ; GM 63791
• Manufacturer Contact: ulrike lindner ; hanauer landstrasse 7a; karlstein, bavaria 63791 ; GM 63791
• MDR Report Key: 5811525
• MDR Text Key: 280443395
• Report Number: 9615005-2016-80002
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• 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 Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2017
• Device Model Number: NNN-2S
• Device Catalogue Number: NNN-2S
• Device Lot Number: X11M556
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization