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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 9MM X 180MM FIXATION, NAIL

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ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 9MM X 180MM FIXATION, NAIL Back to Search Results
Model Number N/A
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 07/27/2018
Event Type  malfunction  
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. (b)(4). Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-08406.
 
Event Description
It was reported that during an affixus hip fracture nail case, the surgeon opened the box to the device, and discovered that the pouches were not sealed on two different nails. A third nail was opened and successfully used to complete the procedure. No adverse events took place. Attempts have been made and no further information has been provided.
 
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Brand NameAFFIXUS HFN 125 DEG 9MM 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 Key7805177
MDR Text Key117923425
Report Number0001825034-2018-08405
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 03/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814309180
Device Lot Number177830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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