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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 30 DEGREE LEFT FASTENER, FIXATION

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ZIMMER BIOMET, INC. EZ PASS 30 DEGREE LEFT FASTENER, FIXATION Back to Search Results
Catalog Number 904056
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdrs were filed in association with this event. Please see: 0001825034 - 2019 - 02792, 0001825034 - 2019 - 02793, 0001825034 - 2019 - 02794, 0001825034 - 2019 - 02799, 0001825034 - 2019 - 02800, 0001825034 - 2019 - 02801, 0001825034 - 2019 - 02802, 0001825034 - 2019 - 02803, 0001825034 - 2019 - 02804, 0001825034 - 2019 - 02805, 0001825034 - 2019 - 02806, 0001825034 - 2019 - 02807. Concomitant medical product(s): 908646 washerloc cortical screw 46mm, lot 305460; 906513 tunneloc fixation lot 465065; 904781 standard ezloc lot 576530; 904755 ziploop lot p08647; 904056 ez pass lot 545450; 904055 ez pass lot 359600; 904053 ez pass lot 048410; 900321 maxfire lot 909090; 904760 toggle drill lot 699980; 912031 juggerknot lot p09905; 912029 juggerknot lot p08797. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified. No patient or surgical involvement. No further information available at this time.
 
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Brand NameEZ PASS 30 DEGREE LEFT
Type of DeviceFASTENER, 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 Key8743561
MDR Text Key162366308
Report Number0001825034-2019-02800
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2021
Device Catalogue Number904056
Device Lot Number545450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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