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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PHOENIX NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. UNKNOWN PHOENIX NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Malposition of Device (2616)
Patient Problem Failure of Implant (1924)
Event Date 07/30/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: unk connecting bolt cat#ni lot#ni; unk connecting bolt cat#ni lot#ni. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02379, 0001825034 - 2021 - 02380.
 
Event Description
It was reported that a patient underwent a revision procedure 3 days after implantation due to a malpositioned nail. The nail position was inadequate due to connecting bolts not attaching correctly to the nail during insertion. There was a 5 hour delay to the procedure. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN PHOENIX NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key12336195
MDR Text Key267127790
Report Number0001825034-2021-02381
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/18/2021 Patient Sequence Number: 1
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