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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7MM CALIB DRILL BIT TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. 2.7MM CALIB DRILL BIT TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 214227070
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/27/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that the instrument fractured and the fractured piece was retained in the patient's body.

 
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Brand Name2.7MM CALIB DRILL BIT
Type of DeviceTRAUMA, 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 Key8925824
MDR Text Key155359376
Report Number0001825034-2019-03776
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number214227070
Device LOT NumberZB170302
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2017
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: 08/23/2019 Patient Sequence Number: 1
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