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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINKBIO ORTHOPEDICS BUTTNER JANZ IVD PITUITARY RONGEUR
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LINKBIO ORTHOPEDICS BUTTNER JANZ IVD PITUITARY RONGEUR Back to Search Results
Model Number 75-6540/20
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/05/2018
Event Type  malfunction  
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
Manufacturer Narrative
The following elements have blank data: device manufacturer's street address: (line 1) for type of device: rongeur.City: for type of device: rongeur.State: for type of device: rongeur.Zip: for type of device: rongeur.
 
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
Manufacturer Narrative
The following elements have blank data.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
The tip of the micropituitary ronguer broke off at its jaw during the procedure.Entire surgical team was made aware.A replacement rongeur was requested and brought into the room.A portion of the instrument was seen on x-ray by attending surgeon.Attempts were made to retrieve the part but was sitting deep inside the disc space.Artifact was felt to be in a safe position and was left.Patient and family were made aware of the incident.
 
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Brand Name
BUTTNER JANZ IVD PITUITARY RONGEUR
Type of Device
RONGEUR
Manufacturer (Section D)
LINKBIO ORTHOPEDICS
101 roundhill drive, 2nd floor
rockaway NJ 07866
MDR Report Key7457717
MDR Text Key106449719
Report Number7457717
Device Sequence Number1
Product Code HTX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number75-6540/20
Device Catalogue Number75-6540/20
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2018
Event Location Hospital
Date Report to Manufacturer04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO; NO; NO; NO; NO; NO; NO
Patient Age52 YR
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