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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG THIN 8IN 3MM RONGEUR, MANUAL

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S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG THIN 8IN 3MM RONGEUR, MANUAL Back to Search Results
Model Number NL4257-83T
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) on 11oct2016, customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available. Confirmation was also requested from the customer that there was no patient impact associated with reported issue. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Customer stated via email: customer states that surgeon was using kerrison during an operation. As surgeon was using kerrison, the rivet that holds the screw in the hinge of the kerrison popped out into the patient. The physician immediately noticed the rivet and retrieved it from patient. Customer states that there was no harm to the patient. Customer informed v. Mueller rep on the afternoon of friday, (b)(6). On 11oct2016 additional information: what was the procedure that was being performed? yes incident occurred during case. Did any part the instrument fall into the patient's body and if so how was it retrieved? the screw fell into the wound; surgeon picked it up with forceps. Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? not necessary, screw fell out and was immediately retrieved. What was the patient's outcome? no affect. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? sales rep took instrument. Do you have the lot#? listed on the sales rep copy.
 
Manufacturer Narrative
(b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in june of 2007. The instrument looks worn and shows repeated repair work performed by unauthorized third party repair companies, such as grinding at the tip as well as on the glider and the main shaft parts. Apparently the screw was not secured appropriately after repair. In addition, the screw returned with the device is not the original screw as per the supplier¿s device master record and device history record. The customer should train its staff that the screws must be checked for tightness after cleaning. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
 
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Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 3MM
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
S&A MARTIN GMBH
uhlandstrasse 17
rietheim-weilheim 78604
GM 78604
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6043215
MDR Text Key57928696
Report Number1423507-2016-00071
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 consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4257-83T
Device Lot NumberXMEG06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2007
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/20/2016 Patient Sequence Number: 1
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