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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 125 DEG 12MM X 165MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN 125 DEG 12MM X 165MM ROD, FIXATION Back to Search Results
Catalog Number 816712165
Device Problem Misassembled (1398)
Patient Problem No Information (3190)
Event Date 09/19/2018
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.
 
Event Description
It was reported that the set screw did not properly assemble with the nail. The surgeon removed the set screw and nail. A backup was used to complete the procedure.
 
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Brand NameHFN 125 DEG 12MM X 165MM
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 Key7952480
MDR Text Key123263265
Report Number0001825034-2018-09150
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PNOT CLEARED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number816712165
Device Lot Number901680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberRES 80755

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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