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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 Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2017
Event Type  malfunction  
Manufacturer Narrative
The device history records, including records of acceptance testing, were reviewed for both devices and found to conform to all process and device specifications. The returned devices were visually inspected in detail and dimensional measurements were made. Both devices had been subject to extensive repair and modification by unauthorized third parties and showed evident signs of extreme wear and tear. Material had been forcefully removed from several parts of the instruments by grinding, reducing the original dimensions of the devices and compromising their cutting function as well as their load capacity. In addition to the above, the individual devices had been specifically damaged as follows: device #1, lot# 27156613: the shape of the device was changed by removal of an essential part required to ensure mechanical safety and functional effectiveness of moving parts of device. The movement of the sliding parts of the device was thus extended and caused additional damage to the tip. Device #2, lot# 27161331: the cutting edge was bent upwards. The device is intended for cutting of bony tissue. However, the tip showed damage typically caused by grasping hard objects such as wire.
 
Event Description
During a surgical case, two kerrison rongeurs malfunctioned and were believed to have fractured. By means of an x-ray, it was confirmed that no part of the instruments had fallen into the patient's body. The patient suffered no impact and the procedure was completed as planned.
 
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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 Key6315376
MDR Text Key67212373
Report Number9611616-2017-00001
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 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4273-82
Device Lot Number27156613 / 27161331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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