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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: 0001825034-2019-05616.
 
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.
 
Event Description
Upon receipt of additional information, it has been determined that this event was previously reported under 0001825034 - 2019 - 05794.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this event was previously reported under 0001825034 - 2019 - 05794 the initial report was forwarded in error and should be voided.
 
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Brand Name
EZ PASS 70 DEGREE RIGHT
Type of Device
FASTENER, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9527649
MDR Text Key200860907
Report Number0001825034-2019-05615
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date04/23/2021
Device Catalogue Number904053
Device Lot Number121740
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
904053 EZ PASS 70 DEGREE RIGHT 022880
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