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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. RONGEUR PITUITARY CER BLACK SERRATED 3MM
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ZIMMER BIOMET SPINE INC. RONGEUR PITUITARY CER BLACK SERRATED 3MM Back to Search Results
Catalog Number 8733-7183
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that the tip of a rongeur was broken while being used to remove a broken competitive implant.The device was used to successfully retrieve all broken pieces of the implant without reported patient impacts.
 
Manufacturer Narrative
Udi number: (b)(4).Additional information: methods, results, and conclusions - the returned rongeur was examined.The jaw pivot pin is missing and the top jaw has disassociated from the bottom jaw making the device no longer functional.The cause of this event can likely be attributed to application of the device outside its intended function.The device is intended to be used to clear the disc space of tissue and was instead used for removal of an implant which may apply a much greater force.A review of the dhr did not find any issues which would have contributed to this event.
 
Event Description
It was reported that the tip of a rongeur was broken while being used to remove a broken competitive implant.The device was used to successfully retrieve all broken pieces of the implant without reported patient impacts.
 
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Brand Name
RONGEUR PITUITARY CER BLACK SERRATED 3MM
Type of Device
RONGEUR
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7658135
MDR Text Key113007017
Report Number3012447612-2018-00546
Device Sequence Number1
Product Code HTX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8733-7183
Device Lot NumberIM00292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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