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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PITUITARY RONGEUR BLACK 3MM LATERAL
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ZIMMER BIOMET SPINE INC. PITUITARY RONGEUR BLACK 3MM LATERAL Back to Search Results
Catalog Number 8733-7153
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 08/31/2018
Event Type  Injury  
Manufacturer Narrative
Udi number: na.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 broke off during surgery.This resulted in a delay longer than 30 minutes in order to retrieve the broken piece from the wound.The procedure was completed using an alternative rongeur.There were no reported patient impacts associated with the delay.
 
Manufacturer Narrative
Additional information: (ethnicity), methods, results, and conclusions: the returned rongeur was examined.The jaw was confirmed to have fractured off.The cause cannot be determined, but similar events have found that the jaws have fractured when high forces were applied, as when the jaw was used to cut bone instead of the disc material.There were no manufacturing issues detected which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding device usage.
 
Event Description
It was reported that the tip of a rongeur broke off during surgery.This resulted in a delay longer than 30 minutes in order to retrieve the broken piece from the wound.The procedure was completed using an alternative rongeur.There were no reported patient impacts associated with the delay.
 
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Brand Name
PITUITARY RONGEUR BLACK 3MM LATERAL
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7930650
MDR Text Key122513564
Report Number3012447612-2018-00794
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 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8733-7153
Device Lot NumberIM00272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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