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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WENZLER GMBH CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE RONGEUR, MANUAL

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WENZLER GMBH CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE RONGEUR, MANUAL Back to Search Results
Model Number NL4273-82
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 04/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). On 4/27/2016 customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available. Confirmation was also requested from the customer that there was no patient impact associated with reported issue. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Customer stated via email: it has a burr on the side and back of the tip, in which it resulted in a tear in the dura. The dura tear was repaired. The patient received a normal recovery and was discharged with special instructions for a dura tear. On 27apr2016 additional information: was the product received in this condition: no. If not, what was the product being used for when it was observed that has a burr on the side and back of the tip: revision right l4/5 lfd. What procedure did the patient have to undergo for the torn dura: the doctor had to do a dura repair, he stitched it with 6-0 prolene suture. Please provide any other details regarding patient impact. Patient had to lay flat for 60 minutes. The patient was discharged with special instructions to follow for a dura tear.
 
Manufacturer Narrative
(b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in june of 2014. The incident is not caused by a burr on the instrument. There is no visible burr present, confirmed through magnification at the tip of the instrument. The instrument failed the cutting test. The jaw of the instrument is bent and in a much worn condition. The tip is damaged by misuse and modification, and the footplate is modified and thereby weakened. The instrument was disassembled by an unauthorized 3rd party repair company. The supplier manufactured and delivered the instrument with a handle screw, which was secured by laser welding dots, so it is not possible that this instrument came apart during surgery. To remove this screw, excessive force with a screwdriver is required. On this instrument, all laser welding dots are broken. It is like a broken seal. Also the screw slot is damaged. The tear in the dura was most likely caused by misuse, worn condition, modification of the instrument by an unauthorized 3rd party repair company, no cutting action, and bending of the instrument through mechanical overload. 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 NameCHROMA-LINE BLUE KERR RONG 8IN 2MM BITE
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
WENZLER GMBH
steigäcker 22
balgheim 78582
GM 78582
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
8473628063
MDR Report Key5656700
MDR Text Key45234481
Report Number1423507-2016-00059
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 07/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4273-82
Device Lot NumberXWDV06
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/16/2016 Patient Sequence Number: 1
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