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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AFFIXUS NAIL ROD, FIXATION

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ZIMMER BIOMET, INC. UNKNOWN AFFIXUS NAIL ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). It has been indicated that the product will not be returned to zimmer biomet for investigation as it was implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the wrong sided affixus nail was placed into the femur and after an x-ray was taken it was noticed that the nail had penetrated the cortex of the femur distally this creating a fracture. Several unsuccessful attempts were made to remove the nail then a plate was applied to fix the fracture distally with the nail still in place.
 
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Brand NameUNKNOWN AFFIXUS NAIL
Type of DeviceROD, FIXATION
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 Key8206429
MDR Text Key131721150
Report Number0001825034-2018-11569
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2019
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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