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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 210MM X 210MM PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 210MM X 210MM PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 14-440221
Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source foreign - event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00919. 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. If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that an operation was performed with a phoenix ankle nail. During the procedure, the connecting portion between the nail and bolt had come off when the surgeon inserted the nail into the patient. The surgeon removed the nail and tried to connect the nail with the bolt; however, it couldn't reconnect. Surgeon then used a backup nail to finish the operation.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual examination of the returned product identified that the threads on both bolt and nail are stripped. The bolt has a potential field age of 8 years. The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameANKLE LOCKING NAIL 11 X 210MM X 210MM
Type of DevicePROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9774666
MDR Text Key198120095
Report Number0001825034-2020-00918
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K081243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-440221
Device Lot Number244390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/02/2020 Patient Sequence Number: 1
Treatment
CONNECTING BOLT CATALOG#: 14-440042 LOT#: PT24A.
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