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 distributor,foreign,health pr report with the FDA on 2016-05-06 for ZNN GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..

Event Text Entries

[44612024] Two guide wire grippers were sent in with this complaint for evaluation. Visual exams and functional tests were performed on both products. Manufacturing records and a technical evaluation showed the guide wire grippers were conforming to the specifications and material information sheet (mis). Both returned products show repeated use indicated by worn etching, dents and scratches, thread damage in one instrument, and guide wire hole damage in the other. The instruments had a potential field age of approximately 3. 5 years at the time of incident with unknown usage history. This device is used for treatment. A functionality test was run on both products and one lot passed and the other lot failed, with use of a 3. 0mm by 70cm guide wire. The failed product from the listed lot number is the part that exhibits hole elongation on both the top strike handle and the pivot plate. Based on information provided, the device has reached the end of its useful life. This issue has been investigated due to previous reports of this nature. A new design was released to increase the hardness of the strike plate and tighten the tolerance of the guide wire holes, which will improve gripping strength as well as durability. This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10


[44612025] It was reported that the guide wire grippers allow wire to slip through them; the guide wire grippers are not gripping properly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2016-01476
MDR Report Key5636960
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2016-05-06
Date of Report2015-03-19
Date of Event2015-03-10
Date Mfgr Received2015-03-19
Device Manufacturer Date2011-09-23
Date Added to Maude2016-05-06
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. CARRIE SCHNEIDER
Manufacturer StreetP.O. BOX 708
Manufacturer CityWARSAW IN 465810708
Manufacturer CountryUS
Manufacturer Postal465810708
Manufacturer Phone8006136131
Manufacturer G1ZIMMER, INC.
Manufacturer Street1800 WEST CENTER STREET
Manufacturer CityWARSAW IN 46580
Manufacturer CountryUS
Manufacturer Postal Code46580
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameZNN GUIDE WIRE GRIPPER
Generic NameHXI
Product CodeHXI
Date Received2016-05-06
Returned To Mfg2015-06-02
Model NumberN/A
Catalog Number00249001200
Lot Number61571814
ID NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER, INC.
Manufacturer Address1800 WEST CENTER STREET WARSAW IN 46580 US 46580


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-06

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