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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN VERSA NAIL FIXATION, NAIL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). Report source, literature - armstrong, l. Et al (2017). Tibiotalocalcaneal nail fixation and soft tissue coverage of gustilo¿anderson grade 3b open unstable ankle fractures in a frail population; a case series in a major trauma centre. Foot and ankle surgery, 1-6. Doi: 10. 1016/j. Fas. 2017. 03. 015. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to 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 in a journal article that a patient developed cellulitis over the flap. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN VERSA NAIL
Type of DeviceFIXATION, NAIL
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 Key6961525
MDR Text Key89726384
Report Number0001825034-2017-09092
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
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: 10/19/2017 Patient Sequence Number: 1
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