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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA PHOENIX RETROGRADE NAIL 13.5MM X 380MM ROD, FIXATION, INTRAMEDULLARY

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BIOMET TRAUMA PHOENIX RETROGRADE NAIL 13.5MM X 380MM ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Degraded (1153); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2017
Event Type  malfunction  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. An examination of the returned devices was not possible. The returned product was scrapped in error, instead of being delivered to the postmarket surveillance lab. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. 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.
 
Manufacturer Narrative
(b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports : this report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-03883 ).
 
Event Description
It was reported that during a trauma femoral nailing procedure, upon attempted implantation, the nail continually disengaged and slipped off the jig. A second nail was attempted with the same results. Eventually, the threads were stripped and neither nail was implanted. A different nail system was utilized to complete the procedure after a twenty-five (25) minute delay to the procedure. No patient consequences were reported as a result of the malfunction.
 
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Brand NamePHOENIX RETROGRADE NAIL 13.5MM X 380MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
BIOMET TRAUMA
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 Key6639471
MDR Text Key195016166
Report Number0001825034-2017-03897
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number14-444438
Device Lot Number446200
Other Device ID Number(01)00888480167204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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