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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT; SPORTS MEDICINE INSTRUMENTATION

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ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT; SPORTS MEDICINE INSTRUMENTATION Back to Search Results
Catalog Number 904053
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified one part with the nitinol kite closed.Second part was returned where one has a broken kite and bio-material blocking the kite.The other one has bio-material blocking the kite from deploying.The ez pass handles moves the nitinol as intended except for the one that is broken.The one with the bio-material moves the nitinol wire but does not deploy it out of the tip.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to off-label use as this device was being used in an open bankart procedure.This instrument is intended to be used arthroscopically.It is unknown which instrument was broken.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03310.
 
Event Description
It was reported that the suture passer instruments did not open up the loop for catching the suture during the open bankart procedure.First time the loop open properly, but with the second suture the loop stayed close.The surgeon tried two (2) extra instruments with the same result.Upon evaluation of the device, fracture was noted on the kite wire.No additional patient consequences are known.
 
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Brand Name
EZ PASS 70 DEGREE RIGHT
Type of Device
SPORTS MEDICINE INSTRUMENTATION
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 Key8845668
MDR Text Key153120688
Report Number0001825034-2019-03309
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/31/2019
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 Date05/17/2021
Device Catalogue Number904053
Device Lot Number438150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/24/2019
Initial Date FDA Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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