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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN FOOTPLATE

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S.U.A. MARTIN GMBH &CO.KG RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN FOOTPLATE Back to Search Results
Catalog Number RD4824M
Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned incomplete (screw missing) and showed evidence of repeated repair work performed by unauthorized third parties. Device in use since 2005, well above its expected lifetime.
 
Event Description
In the middle of surgery it was discovered that the device was missing screw. The device was not in contact with patient. Patient not affected, no injury nor medical intervention required. No delay in surgery.
 
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Brand NameRUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN FOOTPLATE
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 Key5982740
MDR Text Key55787371
Report Number8010386-2016-00008
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRD4824M
Device Lot Number1140814BA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2005
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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