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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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). Product has been received by zimmer biomet and the investigation is in process. 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: 0001825034-2019-05794.
 
Event Description
It was reported that the ez pass would not engage the suture kite and the wire was unable to advance or retract the kite. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon reassessment of the reported event, the device was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the device was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
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Brand NameEZ PASS 70 DEGREE RIGHT
Type of DeviceORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9535152
MDR Text Key201372211
Report Number0001825034-2019-05795
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 distributor,health profession
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number904053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/31/2019 Patient Sequence Number: 1
Treatment
EZ PASS, 70, RIGHT, CAT#: 904053, LOT#: NI
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