• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM MANUAL RONGEUR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

S.U.A. MARTIN GMBH &CO.KG VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM MANUAL RONGEUR Back to Search Results
Catalog Number 2130814BT / NL 4252-83T
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
Correction of event description: examination of the returned device and the broken-off footplate showed that the footplate broke off in a single piece, not several pieces as implied by the initially reported description of the event. The device was subject to microscopic examination by the manufacturer. Visible grinding marks on the slider, handle and tip indicate that it had been repaired and modified by an unauthorized and unknowledgeable third party. The foot plate had been ground by the repair site, reducing material stability and increasing the risk of breakage. This effect was augmented by modification of the limit stop of the handle, permitting greater pressure to be applied to the foot plate during use than intended by the device manufacturer. Manufacturing records were reviewed and no anomalies found. Hardness testing showed that the returned device conformed to specifications.
 
Event Description
Per hospital report, dr. (b)(6) was using a 3mm kerrison on a lumbar fusion and the foot plate broke. All the pieces were removed from the patient. No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM
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 Key9210020
MDR Text Key214346506
Report Number8010386-2019-00003
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 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2130814BT / NL 4252-83T
Device Lot NumberXMEI05
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2008
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: 10/18/2019 Patient Sequence Number: 1
-
-