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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAIMUND WENZLER GMBH CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE

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RAIMUND WENZLER GMBH CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE Back to Search Results
Catalog Number NL4273-82
Device Problem Bent (1059)
Patient Problem Tissue Damage (2104)
Event Date 04/26/2016
Event Type  malfunction  
Manufacturer Narrative
Microscopic evaluation revealed that no burr is present on the device. The instrument had been disassembled by unauthorized service company (safety welding broken by application of force on screw, screw slot damaged). Cutting test failed. The device showed excessive wear, the tip and footplate being damaged by unauthorized repair and/or modification, jaw bent. Review of manufacturing records showed no issues. Customer instructed to perform function check of device before reuse and not to use modified instruments.
 
Event Description
Per customer statement, a burr on the side and back of the tip resulted in a tear in the dura. The dura tear was repaired. The patient recovered normally and was discharged with special instructions for a dura tear. Additional information (04/27/2016): the product was not received in this condition. It was being used for a revision right l4/5 lfd when it was observed that it had a burr on the side and back of the tip. The doctor had to do a dura repair, stitching it with 6-0 prolene suture. The patient had to lay flat for 60 minutes.
 
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Brand NameCHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE
Type of DeviceRONGEUR
Manufacturer (Section D)
RAIMUND WENZLER GMBH
steigaecker 22
balgheim, baden-wuerttemberg 78582
GM 78582
Manufacturer (Section G)
RAIMUND WENZLER GMBH
steigaecker 22
balgheim, baden-wuerttemberg 78582
GM 78582
Manufacturer Contact
martin wenzler
steigaecker 22
balgheim, baden-wuerttemberg 78582
GM   78582
4249582738
MDR Report Key5700143
MDR Text Key47924990
Report Number9611616-2016-00001
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4273-82
Device Lot Number27141981
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/06/2016 Patient Sequence Number: 1
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