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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OLECR PLATE RT 21H 194MM PLATE, FIXATION

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ZIMMER BIOMET, INC. OLECR PLATE RT 21H 194MM PLATE, FIXATION Back to Search Results
Catalog Number 851318606
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2018
Event Type  Malfunction  
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 sterile packaging was found to be damaged.

 
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Brand NameOLECR PLATE RT 21H 194MM
Type of DevicePLATE, FIXATION
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 Key8206093
MDR Text Key131766859
Report Number0001825034-2018-11549
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number851318606
Device LOT Number147030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/29/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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