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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE EZ PASS 30 DEGREE LEFT PASSER

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BIOMET SPORTS MEDICINE EZ PASS 30 DEGREE LEFT PASSER Back to Search Results
Catalog Number 904056
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 02/24/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The reported event could not be confirmed based on limited information received. The ez pass appears to be in good shape with no visible signs of damage. The nitinol component is completely separated from the ez pass making it impossible to recreate the event. Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found. A definitive root cause could not be determined with the available information. Review of the complaint history determined that no further action is required. 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
The following report is submitted to relay additional information. (b)(4).
 
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.
 
Event Description
It is reported during a labral repair, the wire inside the device jammed and would not advance. Due to the inability to slide the wire with the thumb wheel, the device had to be pulled from the patient. A competitor¿s device was used and repositioned within the patient to finish the case. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
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
This follow-up report is being submitted to relay additional information. 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 NameEZ PASS 30 DEGREE LEFT
Type of DevicePASSER
Manufacturer (Section D)
BIOMET SPORTS MEDICINE
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6456596
MDR Text Key112781426
Report Number0001825034-2017-02360
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/04/2019
Device Catalogue Number904056
Device Lot Number776230
Other Device ID NumberSEE H10
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 Received10/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2016
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

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
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