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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG TA KERRISON RONGEUR 8IN 3MM BITE 40 DEG. UP

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S.U.A. MARTIN GMBH &CO.KG TA KERRISON RONGEUR 8IN 3MM BITE 40 DEG. UP Back to Search Results
Catalog Number NL4291-83T / 1630814ZBAT
Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The returned device was inspected. Hardness of device was tested and found to be conforming to specifications. Original manufacturing and quality control records were reviewed and found to be conforming. The returned device was incomplete, i. E. , the screw was missing. Evidence of third-party rework and repair was observed. Apparently, the screw had been removed and was not correctly fixated again after unauthorized repair and rework activities.
 
Event Description
During a procedure, the screw fell out of the rongeur. No harm to patient was reported.
 
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Brand NameTA KERRISON RONGEUR 8IN 3MM BITE 40 DEG. UP
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
MDR Report Key6865303
MDR Text Key86146969
Report Number8010386-2017-00007
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 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4291-83T / 1630814ZBAT
Device Lot NumberXMER12
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2012
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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