ROD GRIPPER 07.02100.001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-12 for ROD GRIPPER 07.02100.001 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[136017893] Udi number: ni. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10


[136017894] It was reported that a rod gripper broke while the surgeon tried to squeeze the mating rod in surgery. The procedure was completed with an alternative instrument. There were no reported patient impacts associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2019-00073
MDR Report Key8333484
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-02-12
Date of Report2019-05-24
Date of Event2019-01-09
Date Mfgr Received2019-05-22
Device Manufacturer Date2018-06-07
Date Added to Maude2019-02-12
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. ASHLEY MCPHERSON
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal80021
Manufacturer Phone3034437500
Manufacturer G1ZIMMER BIOMET SPINE INC.
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal Code80021
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameROD GRIPPER
Generic NameCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDJ
Date Received2019-02-12
Returned To Mfg2019-02-18
Model NumberNA
Catalog Number07.02100.001
Lot Number110870
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-12

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