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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The following report is submitted to relay additional information. Concomitant medical products: cat#: 904054, ez pass 70 degree left, lot#: ni. The reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: 904054, ez pass 70 degree left, 356880. (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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: 0001825034-2017-11102. Discarded.
 
Event Description
It was reported that the item would not pass the wire through the wheels on the device. Therefore, the device did not perform as expected. A replacement was opened from the same lot; however, the same issue occurred. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameEZ PASS 70 DEGREE LEFT
Type of DevicePASSER
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 Key7130398
MDR Text Key267651855
Report Number0001825034-2017-11101
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number904054
Device Lot Number356880
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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