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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT FASTENER, FIXATION Back to Search Results
Catalog Number 904053
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi#: (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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05615.
 
Event Description
It was reported that during right shoulder arthroscopic anterior and posterior labral repair with capsulorrhaphy. The surgeon experienced two malfunctions with the ez-pass. Passer would not advance nitinol kite. No reported harm to the patient.
 
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Brand NameEZ PASS 70 DEGREE RIGHT
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 Key9527636
MDR Text Key203463867
Report Number0001825034-2019-05616
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2021
Device Catalogue Number904053
Device Lot Number022880
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 Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2018
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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