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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 HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP

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S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP Back to Search Results
Catalog Number NL4251-84T / 0140814BT
Device Problems Bent (1059); Inadequate Service (1564); Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2017
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 badly bent at the cutting end, making normal use impossible. It had evidently been subject to forceful manipulation not in line with the instrument's function or normal handling. Evidence of third-party rework and repair was also observed. Apparently the screw had been removed and was not correctly fixated again after the unauthorized repair and rework activities.
 
Event Description
During an acdf, the lower screw of the rongeur came loose and fell into the patient. It was retrieved immediately from the surgical field. The procedure was completed as planned and there was no harm to patient.
 
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Brand NameT-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM 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 Key6790640
MDR Text Key82986695
Report Number8010386-2017-00005
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 08/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4251-84T / 0140814BT
Device Lot NumberMR44 / XMEV11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2014
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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