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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE LEFT; PASSER

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ZIMMER BIOMET, INC. EZ PASS 70 DEGREE LEFT; PASSER Back to Search Results
Model Number N/A
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2018
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 in process of return.
 
Event Description
It was reported that a patient underwent an arthroscopic labral repair.Subsequently, during the procedure, the suture passer of this product did not work correctly, as the nitinol kite would not advance.Another device was opened and the surgery was completed successfully.
 
Event Description
No further information.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as the device was tested and determined to perform as intended.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
EZ PASS 70 DEGREE LEFT
Type of Device
PASSER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7885335
MDR Text Key120589887
Report Number0001825034-2018-08798
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2018
Device Model NumberN/A
Device Catalogue Number904054
Device Lot Number840550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/21/2018
Initial Date FDA Received09/18/2018
Supplement Dates Manufacturer Received11/14/2018
Supplement Dates FDA Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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