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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR 8 INCHES 2MM BITE

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S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR 8 INCHES 2MM BITE Back to Search Results
Catalog Number NL4251-82T / 0120814BT
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2017
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation. Since the lot number has not been provided by the user, it has not been possible to review the device history record. Since the device is not available for testing and evaluation, it has not been possible to confirm the reported problem nor to establish its cause. A review of complaints for the period 2014-2017 revealed that all complaints received with regard to similar failures were due to misuse by the user. Device not returned by user.
 
Event Description
During a laminectomy with posterolateral fusion the tip of a gold #2 kerrison rongeur broke off. The broken tip was retrieved intact by the surgeon. No further information available.
 
Manufacturer Narrative
The device was manufactured in 2010 and subject to extensive reuse, clearly exceeding the expected lifetime of 3 years. Review of manufacturing and quality control records revealed no issues. Hardness testing results were within specifications. The cutting edges of the instrument were worn (blunt) and increased effort would have been required for clinical use, possibly leading to fracture of the cutting edge.
 
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Brand NameT-COAT MICRO HDL KERRISON RONGEUR 8 INCHES 2MM BITE
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer (Section G)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer Contact
markus pauli
uhlandstrasse 17
rietheim-weilheim, 78604
GM   78604
4619668540
MDR Report Key6636074
MDR Text Key77556253
Report Number8010386-2017-00002
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,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4251-82T / 0120814BT
Device Lot NumberKF41
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2010
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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