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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HIP FRACTURE NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. AFFIXUS HIP FRACTURE NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02310. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
 
Event Description
It was reported that during a procedure, the set screw became stuck in the nail. The screw was grinding in the nail and could be heard. Another device was used to complete the procedure. No further information has been provided.
 
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Brand NameAFFIXUS HIP FRACTURE NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7392554
MDR Text Key104276102
Report Number0001825034-2018-02310
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814509180
Device Lot Number065950
Other Device ID Number(01) 00887868038846
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2017
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

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