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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG 8IN 2MM BITE RONGEUR, MANUAL

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S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG 8IN 2MM BITE RONGEUR, MANUAL Back to Search Results
Model Number NL4251-82T
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On 20mar2017, 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.
 
Event Description
Medwatch report (b)(4) received states: during surgery the tip of a gold #2 kerrison rongeur broke off during the procedure. Broken tip was retrieved intact by surgeon. Intended procedure: laminectomy with posterolateral fusion. No further information available.
 
Manufacturer Narrative
(b)(4). The sample was provided and an evaluation was performed. The reported issue that the tip broke off was confirmed through visual examination. The instrument was manufactured in november of 2010. The root cause of the reported issue is due to normal wear and tear for an end of life instrument. The cutting edges are worn (blunt), which means an increased effort was required to use the instrument. The hardness was within tolerance at 45. 3 hrc (range 43-48 hrc). 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.
 
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Brand NameT-COAT MICRO HDL KERR RONG 8IN 2MM BITE
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 Key6428048
MDR Text Key70971711
Report Number1423507-2017-00086
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 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4251-82T
Device Lot NumberXMEM11
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2010
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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