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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT FASTNER, FIXATION

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ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT FASTNER, FIXATION Back to Search Results
Catalog Number 904053
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 products: 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 70 DEGREE RIGHT
Type of DeviceFASTNER, 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 Key8743552
MDR Text Key201507497
Report Number0001825034-2019-02802
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 Date06/19/2021
Device Catalogue Number904053
Device Lot Number048410
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 Manufactured06/19/2018
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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