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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD FORCEP 3X10MM CUP STR 5IN KERRISON RONGEURS

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CAREFUSION, INC LOVE-GRUENWALD FORCEP 3X10MM CUP STR 5IN KERRISON RONGEURS Back to Search Results
Catalog Number NL6092
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
Pr # (b)(4) on (b)(4) 2019 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Via regulatory maude report: during revision of a knee replacement, the upper portion of the jaw of a v mueller nl6092 pituitary forcep broke. The broken portion of the instrument was retrieved. Fda safety report id#. On 11jun2019 additional information: what was the procedure that was being performed? revision of total knee replacement. Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes. Retrieved with forcep. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? it was seen breaking and falling into the femoral canal, and then immediately retrieved. What was the patient¿s outcome? no issues immediately observed. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? yes. Do you have the lot number? possibly, xmee 12. No further information available.
 
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Brand NameLOVE-GRUENWALD FORCEP 3X10MM CUP STR 5IN
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
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 Key8716540
MDR Text Key149014063
Report Number1423507-2019-00010
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL6092
Device Lot NumberXMEE12
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2006
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/20/2019 Patient Sequence Number: 1
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