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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 11MM X 180MM FIXATION, NAIL

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ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 11MM X 180MM FIXATION, NAIL Back to Search Results
Model Number N/A
Device Problems Difficult to Advance (2920); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. (b)(6).
 
Event Description
It was reported that during a hip fracture nailing procedure, the set screw was unable to advance or reverse from its original position and was jammed. No patient consequences were reported as a result of the malfunction. Attempts have been made and no further information has been provided.
 
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Brand NameAFFIXUS HFN 130 DEG 11MM X 180MM
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 Key7876491
MDR Text Key120258781
Report Number0001825034-2018-08719
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814511180
Device Lot Number970890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3120-2018

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