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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 HANDLE KERRISON RONGEUR MANUAL RONGEUR

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S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HANDLE KERRISON RONGEUR MANUAL RONGEUR Back to Search Results
Catalog Number 2130814BT (NL4252-83T)
Device Problems Fracture (1260); Misassembly During Maintenance/Repair (4054)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2019
Event Type  malfunction  
Manufacturer Narrative
The rongeur was returned without the broken-off tip. Inspection of the device revealed evidence of repair and/or rework by unauthorized third parties: (1) grinding marks were visible in the tip area, diminishing material stability and increasing the risk of breakage; and (2) the screw head had been drilled out, destroying the shank and part of the thread and creating the risk of the remainder of the thread falling out. Review of manufacturing documents showed that the device conformed to specifications at the time of release. Hardness of the returned device was tested and found to conform to specifications.
 
Event Description
While in use on a patient during an ortho-spine procedure, the tip of the device broke off and fell into the patient's body. It was retrieved immediately with surgical pickups under direct visualization. The procedure was completed as planned and the patient was discharged the same day.
 
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Brand NameT-COAT MICRO HANDLE KERRISON RONGEUR
Type of DeviceMANUAL 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
MDR Report Key8653002
MDR Text Key146484384
Report Number8010386-2019-00001
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 Risk Manager
Type of Report Initial
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2130814BT (NL4252-83T)
Device Lot NumberXMEI05
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 Received05/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
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: 05/30/2019 Patient Sequence Number: 1
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