• 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 T-COAT MICRO HDL KERR RONG THIN 8IN 1MM KERRISON 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 T-COAT MICRO HDL KERR RONG THIN 8IN 1MM KERRISON RONGEUR Back to Search Results
Catalog Number NL4252-81T / 2110814BT
Device Problems Fracture (1260); Dull, Blunt (2407); Dent in Material (2526)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
The device, which was returned without the broken-off tip, was subjected to microscopic inspection. Notches were observed on the cutting edge. Paired with the general condition of the cutting edge, this suggests that the device was blunt during use. As a result, an increased amount of force would have been required for cutting, causing the tip to break. Hardness of the returned device was tested and found to conform to specifications. Review of manufacturing documents showed no nonconformities nor rework. The original material certificates were also reviewed and found to be conforming. The device conformed to specifications at the time of release. If the tip is returned, the investigation will be reopened.
 
Event Description
The distal tip of the kerrison rongeur broke off and fell into the patient during an acdf procedure performed under fluoroscopy. The fragment was retrieved using a forceps and the procedure was completed as planned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 1MM
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 Key12712428
MDR Text Key278857192
Report Number8010386-2021-00001
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
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4252-81T / 2110814BT
Device Lot NumberK19XME
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2019
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: 10/28/2021 Patient Sequence Number: 1
-
-