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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION CENTRAL SCREW DRILL BIT EXTREMITIES, INSTRUMENT

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ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION CENTRAL SCREW DRILL BIT EXTREMITIES, INSTRUMENT Back to Search Results
Catalog Number 405883
Device Problem Difficult to Insert
Event Date 07/10/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.

 
Event Description

It was reported that during the procedure, the baseplate was impacted, the surgeon attempted to insert the central screw. The screw would not advance through the central hole in the baseplate. A different screw size was then attempted to be inserted but then was also hung up and would not go through. Surgeon then used central drill to see if original hole was issue. The screw would not advance again after using the drill. Surgeon could not insert a central screw and just placed 4 peripheral screws to complete the procedure.

 
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Brand NameCOMPREHENSIVE INSTRUMENTATION CENTRAL SCREW DRILL BIT
Type of DeviceEXTREMITIES, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key8863703
Report Number0001825034-2019-03443
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number405883
Device LOT Number605920
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/06/2019 Patient Sequence Number: 1
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