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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN AF PERC GUIDE WITH HY HOLE INSTRU-SERVE ROD, FIXATION

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ZIMMER BIOMET, INC. ZNN AF PERC GUIDE WITH HY HOLE INSTRU-SERVE ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a.
 
Event Description
It was reported that the guide is not correctly targeting and aligning the recon screws. The guide is reportedly approximately 3 mm off and shooting posterior to the nail. No patient consequences have been reported as a result of the malfunction. Attempts have been made and no further information has been provided at this time.
 
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Brand NameZNN AF PERC GUIDE WITH HY HOLE INSTRU-SERVE
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 Key7905148
MDR Text Key121571169
Report Number0001822565-2018-05159
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number82019908600
Device Lot Number97013675
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 Received02/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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