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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN LAG SCREW ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN LAG SCREW ROD, FIXATION Back to Search Results
Catalog Number 814510110
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: hfn 125 deg 13mm x 180mm pn: 814313180 ln: 123690. Cortical bone scr 5. 0mm x 42mm pn: 814550042 ln: m08921tw a. Hfn a/r screw 100mm pn: 814501100 ln: tk1112300a. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
 
Event Description
It was reported that the patient had a revision procedure to remove the lag screw due to unknown reasons.
 
Manufacturer Narrative
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
No further event information available at the time of this report.
 
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Brand NameAFFIXUS HFN LAG SCREW
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8651626
MDR Text Key146420702
Report Number0001825034-2019-02345
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number814510110
Device Lot NumberTP1111310A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
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