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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 Bent (1059)
Patient Problem No Patient Involvement (2645)
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 a jaw was found bent on a rongeur during a routine inspection.It is unknown when the damage occurred.
 
Manufacturer Narrative
Additional information: methods, results, and conclusions - the returned rongeur was examined.The device is bent at the jaw so the top and bottom no longer align.The cause of this event can likely be attributed to accumulated damage from large applied forces during use over time.A review of the dhr did not find any issues which would have contributed to this event.
 
Event Description
It was reported that a jaw was found bent on a rongeur during a routine inspection.It is unknown when the damage occurred.
 
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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 Key7569470
MDR Text Key110083030
Report Number3012447612-2018-00469
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number8733-7183
Device Lot NumberIM00173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/05/2018
Supplement Dates Manufacturer Received10/27/2018
Supplement Dates FDA Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2015
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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