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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 13MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 13MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 06/11/2018
Event Type  Injury  
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.
 
Event Description
It was reported that during the implantation of a hip fracture nail, the set screw would not deploy. Due to this, the hip fracture nail had to be explanted from the patient. Another hip fracture nail was implanted without incidence. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameAFFIXUS HFN 130 DEG 13MM 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 Key7804645
MDR Text Key117852853
Report Number0001825034-2018-04531
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814513180
Device Lot Number970530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 NumberZ-3132-2018

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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