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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 180MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 180MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 14-440118
Device Problem Device Packaging Compromised (2916)
Patient Problem No Information (3190)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint device has not been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a 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.
 
Event Description
It was reported that when the package was opened, it was noticed that the inner sterile packaging had a foreign material inside. No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay updated and additional information. Complaint sample was evaluated and the reported event was not confirmed. Visual inspection of the returned product determined that the packaging is unsealed and a bug like material was found in the packaging. Dhr was reviewed and no discrepancies were found. As the product was returned opened and unsealed, at this time as the bug could have been introduced after the product was opened. A definitive root cause cannot be determined. 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.
 
Event Description
It was reported that when the package was opened, it was noticed that the inner sterile packaging had a foreign material inside. No adverse events have been reported as a result of the malfunction.
 
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Brand NameANKLE LOCKING NAIL 10 X 180MM
Type of DevicePROSTHESIS, KNEE
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 Key7628571
MDR Text Key111985060
Report Number0001825034-2018-04208
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK091976
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 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-440118
Device Lot Number535740
Other Device ID Number(01)00887868093548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/05/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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