• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S&A MARTIN GMBH TA KERRISON RONG. 8'', 1MM BITE, 40? UP RONGEUR, MANUAL

  • 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
 

S&A MARTIN GMBH TA KERRISON RONG. 8'', 1MM BITE, 40? UP RONGEUR, MANUAL Back to Search Results
Model Number NL4291-81T
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On 27jan2017 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Sales rep stated via email: during a procedure on (b)(6) 2016 it was noticed that the footplate of the kerrison (item# (b)(4)) had broken off. The patient was x-rayed to ensure the broken piece was not inside. The broken piece was reported to be found on the patient¿s top drape. The instrument and broken piece is currently in the possession of or nurse manager at centrastate medical center. No further information available.
 
Manufacturer Narrative
Follow up (b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in may of 2014. The root cause of the reported issue is due to unauthorized third party repair and inadequate functional inspection by healthcare facility prior to initiating procedure. The hardness was tested and found to be within specifications. Manufacturing records were reviewed and found to be conforming. The instrument and broken off tip were subject to microscopic examination. Several deep indentations in the material indicate that it was used to cut and/or manipulate thin, hard objects such as metallic wire. This does not correspond to its intended use (cutting of tissue and bone) and led to a reduction in material stability. Evidence of unauthorized third party repairs were also observed, for example, grinding of tip and cutting edges as well as of the shaft guide, which was shortened at the distal end, thus also reducing material stability and increasing the risk of fracture. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTA KERRISON RONG. 8'', 1MM BITE, 40? UP
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
S&A MARTIN GMBH
uhlandstrasse 17
rietheim-weilheim 78604
GM 78604
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6325480
MDR Text Key67535130
Report Number1423507-2017-00084
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4291-81T
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-