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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 12 X 210MM ROD, FIXATION

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ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 12 X 210MM ROD, FIXATION Back to Search Results
Model Number 14-440321
Device Problems Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930)
Event Date 03/29/2022
Event Type  Injury  
Event Description
The patient underwent phoenix nail implantation due to an infection in the ankle area. During the regular inspection, it was reported that the nail was broken at the screw hole. Hence, a revision procedure was performed where the surgeon found infection again in the patient. No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4). Foreign: (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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 NameANKLE LOCKING NAIL 12 X 210MM
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 Key14246821
MDR Text Key291208462
Report Number0001825034-2022-00887
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K081243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number14-440321
Device Catalogue Number14-440321
Device Lot Number376610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2018
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: 04/28/2022 Patient Sequence Number: 1
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