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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAIMUND WENZLER GMBH FS KERRISON RONGEUR

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RAIMUND WENZLER GMBH FS KERRISON RONGEUR Back to Search Results
Catalog Number NL4273-83 / RW 5834 AU C
Event Type  malfunction  
Manufacturer Narrative
Evidence of extensive reuse of device.Device subject to unauthorized disassembly and modification, possibly weakening spring and leading to fracture of part.Hardness of fractured material tested and found conforming to specs.Device history record found conforming.Harm to patient not possible, since handle part of device outside surgical field during clinical use.Breakage of spring during surgery would affect ease of use by surgeon, not device function itself.Should more information become available, a supplemental report will be filed.
 
Event Description
The instrument was being used when a spring broke in the handle.No harm nor impact to patient.
 
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Brand Name
FS KERRISON RONGEUR
Type of Device
RONGEUR
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 Key5767940
MDR Text Key48712889
Report Number9611616-2016-00004
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 07/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberNL4273-83 / RW 5834 AU C
Device Lot Number27103349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2016
Initial Date Manufacturer Received 02/10/2016
Initial Date FDA Received07/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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