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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Failure to Advance (2524)
Patient Problem No Code Available (3191)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a hip fracture nailing procedure, after the affixus nail and lag screw were implanted into the patient, the operating surgeon attempted to lock the lag screw with the set screw, however the set screw did not advance to lock the lag screw. The surgeon then tried to back off the set screw, but it still did not move. He then removed the lag screw and nail and successfully completed the procedure with another nail and lag screw. No further patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. As the product was returned, it was confirmed that the set screw was jammed in the nail. 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 will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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Brand NameAFFIXUS HFN 125 DEG 11MM X 180MM
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 Key7582311
MDR Text Key110482986
Report Number0001825034-2018-03770
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK100238
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 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814311180
Device Lot Number899880
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2018
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: 06/08/2018 Patient Sequence Number: 1
Treatment
HFN LAG SCREW 10.5MM CATALOG#:814510090 LOT#:UF111
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