ZNN GUIDE WIRE GRIPPER N/A 00249001200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-03 for ZNN GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[113200019] (b)(4). Report source, foreign? Events occurred in (b)(6). 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.
Patient Sequence No: 1, Text Type: N, H10


[113200020] It was reported that during a procedure, the guide wire gripper was not able to hold the guide wire. Another device was utilized to successfully complete the procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5


[134873717] This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. No issue was found upon examination of the returned device. Device history record was reviewed and no discrepancies relevant to the reported event were found. Device analysis indicated that the device met specification. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[134873718] No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2018-03519
MDR Report Key7660845
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-07-03
Date of Report2018-11-28
Date Mfgr Received2018-11-26
Device Manufacturer Date2015-07-16
Date Added to Maude2018-07-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameZNN GUIDE WIRE GRIPPER
Generic NamePASSER, WIRE
Product CodeHXI
Date Received2018-07-03
Returned To Mfg2018-08-06
Model NumberN/A
Catalog Number00249001200
Lot Number63107373
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.